Drugs

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 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…

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…

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 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…

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

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 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

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 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

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 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…

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
• 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…

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…

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

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…

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…

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…

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

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…

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.)

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 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 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…

Testing for Gaucher Disease

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

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

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 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 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,…

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…

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

• Amanda Bridges
• May 29, 2020
• Drugs
• No Comments

On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase…

FDA approves brigatinib for ALK-positive metastatic NSCLC

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

On May 22, 2020, the Food and Drug Administration approved brigatinib (ALUNBRIG®, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Today, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic…

FDA approves ripretinib for advanced gastrointestinal stromal tumor

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK™, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with…

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

On May 15, 2020, the Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA®, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial…

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma…

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

• Amanda Bridges
• May 20, 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…

Now FDA-approved: QINLOCK™ (ripretinib)

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. Today, the FDA also approved FoundationOne® CDx (Foundation Medicine, Inc.)…

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

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

On May 18, 2020, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of…

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

• Amanda Bridges
• May 15, 2020
• Drugs
• No Comments

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma…

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

• Katrina Williams
• May 11, 2020
• Drugs
• No Comments

On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMOTM, Eli Lilly and Company) for the following indications: Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;…

FDA expanded the indication of olaparib to include its combination with bevacizumab

• Katrina Williams
• May 11, 2020
• Drugs
• No Comments

Food and Drug Administration expanded the indication of olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination…

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

• Amanda Bridges
• May 7, 2020
• Drugs
• No Comments

On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTATM, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Today, FDA also approved the FoundationOne CDx assay (Foundation…

Bayer and NeoGenomics Launch the Test4TRKTM Program to Provide Genomic Cancer Testing at No Cost for People Living with Advanced Thyroid and Colorectal Cancers

• Amanda Bridges
• May 7, 2020
• Drugs
• No Comments

Bayer today announced the launch of Test4TRKTM program in collaboration with NeoGenomics, Inc. to offer genomic cancer testing for NTRK gene fusions at no cost for patients with RAI-refractory (RAI-R) differentiated thyroid carcinoma (DTC) and metastatic colorectal cancer (mCRC) with high microsatellite instability (MSI-H). NTRK gene fusions, which have been shown to drive tumor growth, are more commonly found in patients with MSI-H mCRC and RAI-R DTC and may play a role in disease management.