FDA Update
FDA Grants Accelerated Approval to Tepotinib for Patients With Metastatic NSCLC and MET Exon 14–Skipping Alterations
The ASCO Post Staff
On February 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations. VISION Trial Efficacy was demonstrated...
FDA Grants Accelerated Approval to Daratumumab Plus Hyaluronidase-fihj for Newly Diagnosed Light Chain Amyloidosis
The ASCO Post Staff
On January 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to daratumumab plus hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis. ANDROMEDA Trial Efficacy was evaluated i...
FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma
The ASCO Post Staff
On January 22, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) and cabozantinib (Cabometyx) as first-line treatment for patients with advanced renal cell carcinoma. CheckMate 9ER Efficacy was evaluated in CheckMate 9ER, a randomized, open-label trial in p...
FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer
The ASCO Post Staff
Today, the U.S. Food and Drug Administration (FDA) approved relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer. “Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require admi...
FDA Approves Margetuximab-cmkb Plus Chemotherapy for Previously Treated Patients With Metastatic HER2-Positive Breast Cancer
The ASCO Post Staff
On December 16, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb (Margenza) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for met...
FDA Approves Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive ALCL
The ASCO Post Staff
On January 14, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori) for pediatric patients aged 1 year 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 ...
FDA Approves Selinexor for Refractory or Relapsed Multiple Myeloma
The ASCO Post Staff
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The FDA granted selinexor accelerated appr...
FDA Approves Rituximab-arrx, a Biosimilar to Rituximab
The ASCO Post Staff
On December 17, the U.S. Food and Drug Administration (FDA) approved rituximab-arrx (Riabni), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener's granulomatosis), and microscopic...
2020 FDA Approvals of Drugs for Cancer Treatment
The ASCO Post Staff
Over the past year (January to December 2020), the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for older therapeutic agents used in oncology and hematology. A brief review of new approvals appears here. For complete prescribing information for ...
FDA Authorizes Antigen Test as First Over-the-Counter, Fully At-Home Diagnostic Test for COVID-19
The ASCO Post Staff
On December 15, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter, fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral-flow antigen test, a type of test that runs a liquid sample along a su...
FDA Issues Emergency Use Authorization for First COVID-19 Vaccine
The ASCO Post Staff
On December 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of COVID-19 caused by SARS-CoV-2 in individuals aged 16 and older. The EUA allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United State...
FDA Issues Emergency Use Authorization for First COVID-19 Test for Self-Testing at Home
The ASCO Post Staff
On November 17, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home. The Lucira COVID-19 All-In-One Test Kit, which provides rapid results, is a molecular (real-time loop mediated amplification reacti...
FDA Approves Gallium-68 PSMA-11 for PSMA-Targeted PET Imaging in Prostate Cancer
The ASCO Post Staff
On December 1, the U.S. Food and Drug Administration (FDA) approved gallium-68 PSMA-11—the first drug for positron-emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Gallium-68 PSMA-11 is indicated for patients with suspected...
FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
The ASCO Post Staff
Stephen M. Hahn, MD, Commissioner at the U.S. Food and Drug Administration (FDA), recently issued a statement regarding an important step that researchers and medical product sponsors can take to make sure clinical trials for medical products are more inclusive of multiple populations. “We have see...
Venetoclax Combination in Newly Diagnosed AML
The ASCO Post Staff
On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or who have comorbidities precluding int...
FDA Approves Venetoclax Combination Regimen for Certain Adult Patients With AML
The ASCO Post Staff
On October 16, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults age 75 or older or who have comorbidities precluding intensive ...
FDA Approves Remdesivir for Patients With COVID-19 Requiring Hospitalization
The ASCO Post Staff
On October 22, the U.S. Food and Drug Administration (FDA) approved the antiviral drug remdesivir (Veklury) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. Remdesivir should only be administered i...
FDA Extends the Approval of Pembrolizumab for Patients With Classical Hodgkin Lymphoma
The ASCO Post Staff
On October 14, the U.S. Food and Drug Administration (FDA) extended the approval of pembrolizumab (Keytruda) for the following indications: Adult patients with relapsed or refractory classical Hodgkin lymphoma Pediatric patients with refractory classical Hodgkin lymphoma or classical Hodgkin l...
FDA Approves Companion Diagnostic for Three Targeted Therapies for Advanced Ovarian, Breast, and Non–Small Cell Lung Cancers
The ASCO Post Staff
On October 27, 2020, the U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx test for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for alpelisib (Piqra...
Companion Diagnostic to Identify NTRK Fusions in Patients With Solid Tumors Eligible for Larotrectinib Treatment Approved by FDA
The ASCO Post Staff
On October 23, 2020, the U.S. Food and Drug Administration (FDA) approved the next-generation sequencing–based FoundationOne CDx test as a companion diagnostic to identify fusions in the neurotrophic receptor tyrosine kinase (NTRK) genes NTRK1, NTRK2, and NTRK3 in DNA isolated from tumor tissue spec...
FDA Approves Nivolumab Plus Ipilimumab for the First-Line Treatment of Unresectable Malignant Pleural Mesothelioma
The ASCO Post Staff
On October 2, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. CheckMate 743 Efficacy was investigated in CheckMate 743, a randomized, ope...
Novel Indications and New Drugs for the Treatment of Patients With Breast Cancer
The ASCO Post Staff
Over the past year (December 2019–September 2020), the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for therapeutic agents used in breast cancer. Pertuzumab/Trastuzumab/Hyaluronidase-zzxf On June 29, 2020, the FDA approved a new fixed-dose com...
FDA Approves Oral Azacitidine as Maintenance Therapy for Adults With AML in First Remission
The ASCO Post Staff
On September 1, the U.S. Food and Drug Administration (FDA) approved oral azacitidine (Onureg; also known as CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery follow...
FDA Approves Daratumumab Plus Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The ASCO Post Staff
On August 20, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with carfilzomib (Kyprolis) and dexamethasone (DKd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy. Dara...
FDA Approves Atezolizumab Plus Cobimetinib/Vemurafenib for Advanced BRAF V600–Mutated Melanoma
The ASCO Post Staff
On July 30, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab (Tecentriq) plus the MEK inhibitor cobimetinib (Cotellic) and the selective BRAF kinase inhibitor vemurafenib (Zelboraf) for the treatment of patients with advanced BRAF V600 mutation–positive melanoma....
FDA Grants Accelerated Approval to Belantamab Mafodotin-blmf for Pretreated Patients With Relapsed or Refractory Multiple Myeloma
The ASCO Post Staff
On August 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to belantamab mafodotin-blmf (Blenrep), an anti-B-cell maturation antigen antibody-drug conjugate, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, in...
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma
The ASCO Post Staff
On July 24, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (Tecartus), a CD19-directed genetically modified autologous T-cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. “Tremendous progr...
FDA Approves Pembrolizumab for Adults and Children With Tumor Mutational Burden–High Solid Tumors
The ASCO Post Staff
On June 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) 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 Approves Oral Combination of Decitabine and Cedazuridine for Adult Patients With Myelodysplastic Syndromes
The ASCO Post Staff
On July 7, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi) for adult patients with myelodysplastic syndromes (MDS), including the following: Previously treated and untreated de novo and secondary MDS with the following French/Americ...
FDA Approves Maintenance Avelumab for the Treatment of Advanced Urothelial Carcinoma
The ASCO Post Staff
On June 30, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. JAVELIN Bladder 100 Efficacy of avelumab...
FDA Extends Indication of Gemtuzumab Ozogamicin for Pediatric Patients With CD33-Positive AML
The ASCO Post Staff
On June 16, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients aged 1 month and older. AAML0531 Efficacy and safety in the pediatric population were sup...
FDA Grants Accelerated Approval to Lurbinectedin for Metastatic SCLC
The ASCO Post Staff
On June 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca) for adult patients with metastatic small cell lung cancer (SCLC) whose disease progressed on or after platinum-based chemotherapy. PM1183-B-005-14 Trial Efficacy was demonstrated in the...
FDA Collaborating on Use of Real-World Data to Inform COVID-19 Response Effort
The ASCO Post Staff
On June 18, 2020, the U.S. Food and Drug Administration (FDA) took an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. The FDA announced its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stak...
FDA Approves Pembrolizumab for the First-Line Treatment of MSI-H/dMMR Colorectal Cancer
The ASCO Post Staff
On June 29, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer. KEYNOTE-177 Approval was based on KEYNOT...
FDA Approves Selinexor for Relapsed or Refractory DLBCL
The ASCO Post Staff
On June 22, the U.S. Food and Drug Administration (FDA) approved oral selinexor (Xpovio), a first-in-class, selective inhibitor of nuclear export compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified after at least two...
FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-Positive Breast Cancer
The ASCO Post Staff
On June 29, the U.S. Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) for subcutaneous injection in the following indications: Use in combination with chemotherapy as: Neoadjuvant treatment for patients with ...
FDA Grants Accelerated Approval to Tazemetostat for Some Patients With Follicular Lymphoma
The ASCO Post Staff
On June 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have recei...
FDA Announces Project Patient Voice to Communicate Patient-Reported Outcomes From Cancer Clinical Trials
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer ...
FDA Approves Nivolumab for Pretreated Patients With Esophageal Squamous Cell Carcinoma
The ASCO Post Staff
On June 10, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. ATTRACTION-3 Efficacy was investigated in ATTRACTI...
FDA Approves Pegfilgrastim Biosimilar, Pegfilgrastim-apgf
The ASCO Post Staff
On June 11, the U.S. Food and Drug Administration (FDA) approved a biosimilar to pegfilgrastim (Neulasta), pegfilgrastim-apgf (Nyvepria), to decrease the incidence of febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically...
FDA Approves Atezolizumab for the First-Line Treatment of Patients With Metastatic NSCLC and High PD-L1 Expression
The ASCO Post Staff
On May 18, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (PD-L1 stained ≥ 50% of tumor cells or P...
FDA Approves Nivolumab/Ipilimumab Plus Chemotherapy for First-Line Treatment of Metastatic or Recurrent NSCLC
The ASCO Post Staff
On May 26, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) with no epidermal growt...
FDA Approves Brigatinib for ALK-Positive Metastatic NSCLC
The ASCO Post Staff
On May 22, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. The FDA also approved the Vysis ALK Break Apart FISH Probe Kit a...
FDA Approves Combination Regimens in NSCLC, HCC
The ASCO Post Staff
On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved two combination regimens: ramucirumab (Cyramza) was approved in combination with erlotinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) ex...
FDA Approves Niraparib as Maintenance Therapy for Advanced Ovarian Cancer
The ASCO Post Staff
On April 29, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. PR...
FDA Approves New Pembrolizumab Dosing Regimen
The ASCO Post Staff
On April 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new dosing regimen for pembrolizumab (Keytruda)—400 mg every 6 weeks—across all currently approved adult indications, in addition to the current 200 mg every 3 weeks dosing regimen. The approval was based on ...
FDA Approves Selpercatinib for Lung and Thyroid Cancers With RET Mutations or Fusions
The ASCO Post Staff
On May 8, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo) 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...
FDA Approves Capmatinib for Patients With Metastatic NSCLC With Confirmed MET Exon 14 Skipping
The ASCO Post Staff
On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta) 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 a...
FDA Approves Daratumumab and Hyaluronidase-fihj in Multiple Myeloma
The ASCO Post Staff
On May 1, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adult patients with newly diagnosed, relapsed, or refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. Daratumumab and hyaluronidase-fihj i...
FDA Issues Emergency Use Authorization for Remdesivir for Treatment of Severe COVID-19
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as low bloo...
