News

FDA

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

  • Amanda Bridges
  • May 28, 2021
  • Drugs
  • No Comments

On May 28, 2021, the Food and Drug Administration granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. The FDA also approved FoundationOne®…

Amgen

FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC

  • Amanda Bridges
  • May 28, 2021
  • Drugs
  • No Comments

On May 28, 2021, the Food and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C ‑mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA ‑approved test, who have received at least one prior systemic therapy. FDA also…

FDA

FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

  • Amanda Bridges
  • May 21, 2021
  • Drugs
  • No Comments

On May 21, 2021, the Food and Drug Administration granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), a bispecific antibody directed against epidermal growth factor (EGF) and MET receptors, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected…

Bristol Myers Squibb

FDA approves nivolumab for resected esophageal or GEJ cancer

  • Amanda Bridges
  • May 20, 2021
  • Drugs
  • No Comments

On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Efficacy was evaluated in CHECKMATE-577 (NCT02743494), a randomized, multicenter, double-blind trial in 794 patients with completely resected (negative margins) esophageal…

Merck

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

  • Amanda Bridges
  • May 6, 2021
  • Drugs
  • No Comments

On May 5, 2021, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Approval was based on the prespecified interim analysis of…

GlaxoSmithKline

FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer

  • Amanda Bridges
  • April 26, 2021
  • Drugs
  • No Comments

On April 22, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior  platinum-containing regimen. Efficacy was evaluated based on cohort (A1) in GARNET…

FDA

FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma

  • Amanda Bridges
  • April 26, 2021
  • Drugs
  • No Comments

On April 23, 2021, the Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising…

Bristol Myers Squibb

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma

  • Amanda Bridges
  • April 16, 2021
  • Drugs
  • No Comments

On April 16, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Efficacy was evaluated in CHECKMATE-649 (NCT02872116), a randomized, multicenter, open-label trial that enrolled 1,581 patients with previously untreated advanced or metastatic…

Immunomedics

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

  • Amanda Bridges
  • April 13, 2021
  • Drugs
  • No Comments

On April 13, 2021, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Efficacy and safety were evaluated in TROPHY…

FDA

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

  • Amanda Bridges
  • April 7, 2021
  • Drugs
  • No Comments

On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. In April 2020, sacituzumab govitecan received accelerated approval…

FDA

FDA approves new dosing regimen for cetuximab

  • Amanda Bridges
  • April 7, 2021
  • Drugs
  • No Comments

On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). This approval provides for a biweekly…

FDA

FDA approves isatuximab-irfc for multiple myeloma

  • Amanda Bridges
  • April 1, 2021
  • Drugs
  • No Comments

On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. The efficacy and safety of isatuximab-irfc in combination with carfilzomib and dexamethasone…

Bristol Myers Squibb

FDA approves idecabtagene vicleucel for multiple myeloma

  • Amanda Bridges
  • March 29, 2021
  • Data
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

FDA

FDA approves pembrolizumab for esophageal or GEJ carcinoma

  • Amanda Bridges
  • March 23, 2021
  • Drugs
  • No Comments

On March 22, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or…

FDA

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

  • Amanda Bridges
  • March 11, 2021
  • Drugs
  • No Comments

Food and Drug Administration approved tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. . March 10, 2021. More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tivozanib-relapsed-or-refractory-advanced-renal-cell-carcinoma

Kite

FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma

  • Amanda Bridges
  • March 8, 2021
  • Drugs
  • No Comments

On March 5, 2021, the Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Approval in FL was based on a single-arm, open-label, multicenter trial (ZUMA-5; NCT03105336) that evaluated axicabtagene ciloleucel, a…

Janssen | Johnson & Johnson

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

  • Amanda Bridges
  • March 4, 2021
  • Drugs
  • No Comments

Action Advances Fight Against COVID-19, Follows Comprehensive Evaluation of Available Safety, Effectiveness and Manufacturing Quality Information by FDA Career Scientists, Input from External Experts Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome…

FDA

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma

  • Amanda Bridges
  • March 1, 2021
  • Drugs
  • No Comments

Food and Drug Administration granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal…

Sanofi Genzyme

FDA approves Regeneron, Sanofi’s Libtayo for first-line advanced NSCLC with high PD-L1 expression

  • Amanda Bridges
  • February 25, 2021
  • Drugs
  • No Comments

(Sanofi) Feb 22, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Read more >

FDA

FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression

  • Amanda Bridges
  • February 22, 2021
  • Drugs
  • No Comments

On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by…

FDA

Now Approved as Early as 1st Relapse

  • Amanda Bridges
  • February 11, 2021
  • News
  • No Comments

XPOVIO® (selinexor) is now FDA approved in combination with bortezomib and dexamethasone (XVd) to treat adult patients with multiple myeloma who have received at least one prior therapy.1 The efficacy of XPOVIO in combination with Vd was evaluated in BOSTON, a global, randomized, open‑label, active‑controlled, phase 3 trial in adult patients who had received 1 to 3…

Sanofi Genzyme

FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma

  • Amanda Bridges
  • February 11, 2021
  • Drugs
  • No Comments

PARIS and TARRYTOWN, N.Y. – February 9, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with an hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted…

FDA

COVID-19 Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 – Drug Information Update

  • Amanda Bridges
  • February 11, 2021
  • Drugs
  • No Comments

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk…

FDA

FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma

  • Amanda Bridges
  • February 10, 2021
  • Drugs
  • No Comments

On February 9, 2021, the Food and Drug Administration granted regular approval to cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC (mBCC)…

FDA

FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma

  • Amanda Bridges
  • February 9, 2021
  • Drugs
  • No Comments

On February 5, 2021, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell…

Bristol Myers Squibb

FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma

  • Amanda Bridges
  • February 9, 2021
  • Drugs
  • No Comments

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the…

EMD Serono

FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer

  • Amanda Bridges
  • February 4, 2021
  • Drugs
  • No Comments

On February 3, 2021, the Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Efficacy was demonstrated in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced…

Daiichi-Sankyo

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

  • Amanda Bridges
  • January 20, 2021
  • Drugs
  • No Comments

On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Efficacy was evaluated in a multicenter, open-label, randomized trial (DESTINY-Gastric01, NCT03329690) in patients with HER2-positive locally advanced or metastatic…

Pfizer

FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma

  • Amanda Bridges
  • January 20, 2021
  • Drugs
  • No Comments

On January 14, 2021, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or…

Oppose the Most Favored Nation Interim Final Rule

  • FLASCO
  • January 8, 2021
  • News
  • No Comments

The Florida Society of Clinical Oncology has opposed the MFN Model since its release and is pleased it did not go into effect on January 1. However, given the devastating impact the model would have on people with cancer, ASCO will continue to advocate for a full withdrawal of the proposal.    CMS estimates that the…

Lilly

Making you aware of a new molecular testing program in thyroid cancer

  • Amanda Bridges
  • December 15, 2020
  • News
  • No Comments

The Thyroid Cancer Testing Program is designed to provide access to molecular testing for appropriate advanced or metastatic medullary thyroid cancer (“MTC”) patients 12 years of age and older who require systemic therapy and advanced or metastatic non-medullary thyroid cancer (“non-MTC”) patients 12 years of age and older who are radioactive iodine-refractory (if radioactive iodine is appropriate)….

Blueprint Medicines

FDA approves pralsetinib for RET-altered thyroid cancers

  • Amanda Bridges
  • December 8, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

FDA

FDA approves device for treatment of osteoid osteoma in the extremities

  • Amanda Bridges
  • November 30, 2020
  • News
  • No Comments

On November 27, 2020, the Food and Drug Administration approved the Sonalleve MR-HIFU system (Profound Medical Inc.) for the treatment of osteoid osteoma in the extremities. MR-guided High Intensity Focused Ultrasound (MR-HIFU) treatment is an image guided technique combining high intensity focused ultrasound ablation with real time monitoring of temperature change during the sonication. The…

FDA

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

  • Amanda Bridges
  • November 30, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

Merck

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

  • Amanda Bridges
  • November 17, 2020
  • Drugs
  • No Comments

Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. November 13, 2020.  More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-pembrolizumab-locally-recurrent-unresectable-or-metastatic-triple

Foundation Medicine

FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers

  • Amanda Bridges
  • November 9, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

ASCO

FDA Approves FoundationOne CDx As Companion Diagnostic For Larotrectinib To Identify NTRK1/2/3 Gene Fusions Across Solid Tumors

  • Amanda Bridges
  • November 5, 2020
  • Drugs
  • No Comments

OncLive (10/23) reported, “The FDA has approved the FoundationOne CDx (F1CDx)comprehensive genomic test as a companion diagnostic for larotrectinib (Vitrakvi) to identify patients with NTRK1/2/3 gene fusions across all solid tumors.” The test “is currently the sole FDA-approved tissue-based comprehensive genomic profiling assay that is indicated to detect NTRK1/2/3 fusions across all solid malignancies and identify…

FDA

FDA Approves VEKLURY (Remdesivir)

  • Kelly Wilson
  • October 25, 2020
  • Drugs
  • No Comments

On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved VEKLURY (remdesivir) for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. VEKLURY should only be administered intravenously (IV) in a hospital or in a healthcare…

Genentech

FDA Grants Full Approval For Venclexta In AML

  • Kelly Wilson
  • October 22, 2020
  • Drugs
  • No Comments

On Friday, the FDA granted full approval for Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this…

Bristol Myers Squibb

FDA Approves Opdivo + Yervoy for Previously Untreated Unresectable Malignant Pleural Mesothelioma

  • Amanda Bridges
  • October 8, 2020
  • Drugs
  • No Comments

Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2 Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1 Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall PRINCETON,…

Blueprint Medicines

FDA Approves GAVRETO (Pralsetinib) For Adult Patients with Metastatic Rearranged During Transfection Fusion-Positive Non-Small Cell Lung Cancer

  • Amanda Bridges
  • October 2, 2020
  • Drugs
  • No Comments

On September 4, 2020, the U.S. Food and Drug Administration (FDA) approved GAVRETO (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Select patients for treatment with GAVRETO based on the presence of a RET gene fusion. Information on…

Celgene

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

  • Amanda Bridges
  • September 4, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

Celgene

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

  • Amanda Bridges
  • September 3, 2020
  • Drugs
  • No Comments

On September 1, 2020, the Food and Drug Administration approved azacitidine tablets (ONUREG®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. More information.

Bristol Myers Squibb

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

  • Amanda Bridges
  • September 3, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

Janssen | Johnson & Johnson

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma

  • Amanda Bridges
  • August 27, 2020
  • Drugs
  • No Comments

On August 20, 2020, the Food and Drug Administration approved carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc.) and daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The efficacy of carfilzomib and daratumumab with dexamethasone was evaluated in two…

Guardant Health

FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

  • Amanda Bridges
  • August 13, 2020
  • Drugs
  • No Comments

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine…

GlaxoSmithKline

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

  • Amanda Bridges
  • August 6, 2020
  • Drugs
  • No Comments

On August 5, 2020, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Belantamab mafodotin-blmf was evaluated in DREAMM-2 (NCT 03525678), an open-label, multicenter trial….

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

  • Amanda Bridges
  • August 4, 2020
  • Drugs
  • No Comments

On July 31, 2020, the Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for…

Genentech

FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma

  • Amanda Bridges
  • July 31, 2020
  • Drugs
  • No Comments

On July 30, 2020, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Efficacy in combination with cobimetinib and vemurafenib was evaluated in a double-blind, randomized (1:1), placebo-controlled, multicenter trial (IMspire150, NCT02908672) in 514 patients. After a 28-day…

Kite

FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL

  • Amanda Bridges
  • July 30, 2020
  • Drugs
  • No Comments

Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy…

Kite

FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL

  • Amanda Bridges
  • July 27, 2020
  • Drugs
  • No Comments

On July 24, 2020, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first…

Genentech

Announcing a New Genentech Therapy

  • Amanda Bridges
  • July 16, 2020
  • Drugs
  • No Comments

Genentech is excited to share the news of the Food and Drug Administration (FDA) approval of PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use. PHESGO is a fixed-dose combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase. Indications Early Breast Cancer PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with…

Taiho Oncology

FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home – Drug Information Update

  • Amanda Bridges
  • July 8, 2020
  • Drugs
  • No Comments

Today, the U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). This represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a health care facility to receive…

Dr. Cassell

In Memory of Dr. Robert Cassell

  • Amanda Bridges
  • July 3, 2020
  • News
  • No Comments

With heavy hearts, FLASCO is saddened to announce the passing of longtime FLASCO member, Robert ‘Bob’ Cassell, MD, PhD.  Dr. Cassell passed away Tuesday, June 30th in Winter Haven, Florida, after battling COVID.  Dr. Cassell was a longtime member of FLASCO, serving on the Board of Directors for many years, and as FLASCO President from…

EMD Serono

FDA approved avelumab 6/30/2020

  • Amanda Bridges
  • July 2, 2020
  • Drugs
  • No Comments

Food and Drug Administration approved avelumab (BAVENCIO, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. More Information. June 30, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

Genentech

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

  • Amanda Bridges
  • July 2, 2020
  • Drugs
  • No Comments

On June 29, 2020, the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO®, Genentech, Inc.) for subcutaneous injection for the following indications: Use in combination with chemotherapy as: • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm…

Merck

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer – Drug Information Update

  • Amanda Bridges
  • June 30, 2020
  • Drugs
  • No Comments

The U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving…

Genentech

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

  • Amanda Bridges
  • June 30, 2020
  • Drugs
  • No Comments

On June 29, 2020, the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO®, Genentech, Inc.) for subcutaneous injection for the following indications: Use in combination with chemotherapy as: • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm…

Merck

FDA approved approved pembrolizumab colorectal cancer

  • Amanda Bridges
  • June 30, 2020
  • Drugs
  • No Comments

Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. More Information. June 29, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-first-line-treatment-msi-hdmmr-colorectal-cancer  Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

Genentech

FDA Grants Approval to New Fixed-Dose Combination of Perjeta and Herceptin

  • Amanda Bridges
  • June 30, 2020
  • Drugs
  • No Comments

Genentech announced the FDA granted approval to Phesgo, a new fixed-dose combination of Perjeta and Herceptin available in a single vial. It can be administered under the skin (subcutaneous injection) in just minutes, significantly reducing the amount of time a patient spends receiving treatment when compared to hours with IV administration. The Genentech press release…

CareASSIST Patient Support by Sanofi Genzyme

  • FLASCO
  • June 26, 2020
  • News
  • No Comments

At the CareASSIST Program by Sanofi Genzyme, our mission is to deliver support services to eligible patients through reliable reimbursement and financial assistance programs. Our dedicated team of CareASSIST Patient Access Specialists strives to ensure that these patients are able to access support through our program. Access and Reimbursement Assistance navigating the insurance process, including…

FDA

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

  • Amanda Bridges
  • June 26, 2020
  • Drugs
  • No Comments

On June 24, 2020, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Efficacy was investigated in KEYNOTE-629 (NCT03284424), a multicenter, multi-cohort, non-randomized, open-label trial. The trial excluded patients who had previously received…

FDA Approval of XPO1 Inhibitor Compound

  • Katrina Williams
  • June 24, 2020
  • Drugs
  • No Comments

Karyopharm Therapeutics Inc. is proud to announce the FDA approval of their lead XPO1 inhibitor compound to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). To learn more about this recent approval, please see the full press release here. (For XPOVIO®(selinexor) full Prescribing Information please visit: XPOVIO Full Prescribing Information.)

Epizyme

FDA granted accelerated approval to tazemetostat for follicular lymphoma

  • FLASCO
  • June 23, 2020
  • Drugs
  • No Comments

On June 18, 2020, the Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK™, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies,…

A product-specific J-code for an mUC treatment is now available

  • Amanda Bridges
  • June 19, 2020
  • Drugs
  • No Comments

  We are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020.1 * Note that the product’s NDC code…

FDA

FDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients

  • Amanda Bridges
  • June 18, 2020
  • Drugs
  • No Comments

On June 16, 2020, the Food and Drug Administration extended the indication of gemtuzumab ozogamicin (MYLOTARGTM, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older. Efficacy and safety in the pediatric population were supported by data from AAML0531 (NCT00372593), a multicenter randomized study of 1,063 patients…

FDA

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

  • Amanda Bridges
  • June 18, 2020
  • Drugs
  • No Comments

Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment…

Janssen | Johnson & Johnson

COVID-19 Pandemic, New Health Policies and Resources

  • Amanda Bridges
  • June 17, 2020
  • News
  • No Comments

As our healthcare industry rapidly evolves to address the COVID-19 pandemic, new health policies and resources especially in the areas of patient affordability, care delivery and provider reimbursement continue to be released. That is why we have engaged Avalere, the health policy research firm, to develop and update a repository cataloging significant health policy changes….

Daiichi-Sankyo

ENHERTU® (fam-trastuzumab deruxtecan-nxki)

  • Amanda Bridges
  • June 17, 2020
  • Drugs
  • No Comments

Effective July 1, 2020, ENHERTU® (fam-trastuzumab deruxtecan-nxki) will have a permanent j-code: J9358. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting.1 This indication is approved under accelerated…

Genentech

Genentech is excited to share the news of the new FDA approved indication TECENTRIQ®

  • Amanda Bridges
  • June 16, 2020
  • Drugs
  • No Comments

Genentech is excited to share the news of the new FDA approved indication. TECENTRIQ® (atezolizumab), in combination with bevacizumab, is indicated for the first-line (1L) treatment of unresectable or metastatic hepatocellular carcinoma (HCC) treatment. Please see attached for additional information, as well as the TECENTRIQ and the Avastin full Prescribing Information, and Important Safety Information for…

FDA

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

  • Amanda Bridges
  • June 16, 2020
  • Drugs
  • No Comments

On June 15, 2020, the Food and Drug Administration granted accelerated approval to lurbinectedin (ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Efficacy was demonstrated in the PM1183-B-005-14 trial (Study B-005; NCT02454972), a multicenter open-label, multi-cohort study enrolling 105 patients with…

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

  • Amanda Bridges
  • June 5, 2020
  • Drugs
  • No Comments

On May 29, 2020, the Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Efficacy was evaluated in RELAY (NCT02411448), a multinational, randomized, double-blind, placebo-controlled,…

Genentech

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

  • Amanda Bridges
  • June 5, 2020
  • Drugs
  • No Comments

On May 29, 2020, the Food and Drug Administration approved atezolizumab in combination with bevacizumab (TECENTRIQ® and AVASTIN®, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable or metastatic hepatocellular…

GlaxoSmithKline

Complimentary Webinar Series on Multiple Myeloma – GSK

  • Amanda Bridges
  • June 5, 2020
  • News
  • No Comments

You are invited to a 1 hour webinar, Current and Emerging Trends in Multiple Myeloma, presented by Dr. David Vesole, Myeloma Division and Director, Myeloma Research at the John Theurer Cancer Center at Hackensack. Several different dates and time to choose from in June.

ASCO Virtual Direct™ Highlights Jacksonville | Total Health Conferencing

  • Amanda Bridges
  • June 5, 2020
  • News
  • No Comments

Due to COVID-19, the ASCO Direct™ Highlights meeting will be virtual. The 2020 ASCO Direct™ Highlights meeting will offer the same benefit that you have come to depend on. The abstracts chosen for presentation and discussion reflect the foremost research and strategies in oncology that directly impact patient care. Expert faculty will place abstract findings into clinical context and discuss how the results may change the current standard of care. Our conferencing platform allows for presentation, discussion, analysis, and attendee participation.

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