FLASCO / News

FDA Approves Enfortumab Vedotin For Locally Advanced/Metastatic Urothelial Carcinoma

Amanda Bridges
July 12, 2021
Drugs
No Comments

Enfortumab vedotin-ejfv has been approved by the FDA for locally advanced or metastatic urothelial cancer. The FDA has approved enfortumab vedotin-ejfv (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously undergone treatment with a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy or who are otherwise ineligible for…

Reaching Across the Aisle: Cardio-Oncology Advocacy and Program Building

Amanda Bridges
July 12, 2021
News
No Comments

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

Amanda Bridges
July 12, 2021
Drugs
No Comments

On July 9, 2021, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Efficacy was evaluated in APOLLO (NCT03180736), an open-label, active-controlled…

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer

Amanda Bridges
July 9, 2021
Drugs
No Comments

On July 9, 2021, the Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or are ineligible for…

Jazz Pharmaceuticals Announces U.S. FDA Approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Amanda Bridges
July 1, 2021
Drugs
No Comments

Approval under U.S. FDA’s Real-Time Oncology Review program represents an important therapeutic advance for pediatric and adult patients who develop hypersensitivity to E. coli-derived asparaginase treatmentsRylaze is expected to become commercially available in the U.S. in mid-JulyCompany to host investor webcast in July; details to follow DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced…

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

Amanda Bridges
July 1, 2021
Drugs
No Comments

Today, the U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. The only other FDA-approved drug for such patients…

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma

Amanda Bridges
July 1, 2021
Drugs
No Comments

On June 30, 2021, the Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. Efficacy…

FDA approves avapritinib for advanced systemic mastocytosis

Amanda Bridges
June 16, 2021
Drugs
No Comments

On June 16, 2021, the Food and Drug Administration approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Efficacy was evaluated in EXPLORER (NCT02561988) and PATHFINDER (NCT03580655), two multi-center, single-arm,…

FDA warns that vapors from alcohol-based hand sanitizers can have side effects

Amanda Bridges
June 16, 2021
News
No Comments

The U.S. Food and Drug Administration (FDA) is warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin. These symptoms are likely to have occurred because of vapors from the hand sanitizer, potentially from exposure in enclosed spaces or places with poor air circulation. We have…

Disparities in Cancer Care and Health Equity Summit 2021

Amanda Bridges
June 7, 2021
Diversity & Inclusion
No Comments

FLASCO is bringing together leaders in cancer disparities and health equity to advance the understanding of and promote their elimination. Cancer disparities represent a major public health problem in our state, and across the country. Professionals from academic, industry, and the community are coming together, with the shared mission of closing health equity gaps, and…

Support FLASCO Foundation

Amanda Bridges
May 31, 2021
News
No Comments

Not only is Memorial Day an important time to remember those who have given the ultimate sacrifice to protect our country, but it is a day to spend quality time with family and friends as a kickoff to summer. The holiday weekend is usually filled with large gatherings, parades, picnics, or weekend trips. Obviously, in…

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®…

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 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…

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…

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…

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 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…

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…

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 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 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 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…

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 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 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

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…

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 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…

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 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…

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…

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…

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 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 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…

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…

FDA Approves Karyopharm Therapeutics’ Selinexor for Refractory or Relapsed Multiple Myeloma

Amanda Bridges
February 5, 2021
Drugs
No Comments

On December 18, 2020, the Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Read More HERE>>

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…

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…

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…

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)….

FDA approves pralsetinib for RET-altered thyroid cancers

Amanda Bridges
December 8, 2020
Drugs
No Comments

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

Amanda Bridges
November 30, 2020
Drugs
No Comments

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

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

Amanda Bridges
November 9, 2020
Drugs
No Comments

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 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…

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…

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,…

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…

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

Amanda Bridges
September 4, 2020
Drugs
No Comments

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.

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

Amanda Bridges
September 3, 2020
Drugs
No Comments

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…

CAR T-Cell Therapy Approved by FDA for Mantle Cell Lymphoma

Amanda Bridges
August 27, 2020
News
No Comments

A CAR T-cell therapy called brexucabtagene autoleucel (Tecartus) has been approved by the Food and Drug Administration (FDA) for some patients with mantle cell lymphoma. This is the third CAR-T cell therapy approved by FDA for patients with cancer. Read more >

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…

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…

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…

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…

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…

Announcing a New Genentech Therapy

Amanda Bridges
July 16, 2020
Drugs
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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…

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

Amanda Bridges
July 8, 2020
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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…

In Memory of Dr. Robert Cassell

Amanda Bridges
July 3, 2020
News
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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…

FDA approved avelumab 6/30/2020

Amanda Bridges
July 2, 2020
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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

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

Amanda Bridges
July 2, 2020
Drugs
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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…

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

Amanda Bridges
June 30, 2020
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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…

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

Amanda Bridges
June 30, 2020
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FDA approved approved pembrolizumab colorectal cancer

Amanda Bridges
June 30, 2020
Drugs
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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

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

Amanda Bridges
June 30, 2020
Drugs
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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
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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 approves pembrolizumab for cutaneous squamous cell carcinoma

Amanda Bridges
June 26, 2020
Drugs
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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
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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.)

FDA granted accelerated approval to tazemetostat for follicular lymphoma

FLASCO
June 23, 2020
Drugs
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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
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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 approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients

Amanda Bridges
June 18, 2020
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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 approves pembrolizumab for adults and children with TMB-H solid tumors

Amanda Bridges
June 18, 2020
Drugs
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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…

Testing for Gaucher Disease

Amanda Bridges
June 18, 2020
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Gaucher disease is a lifelong, progressive disease. Test to know. It’s a simple blood test. Learn more!