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FDA Update

Gastroesophageal Cancer

FDA Approves Nivolumab in Combination With Chemotherapy for Metastatic Gastric Cancer and Esophageal Adenocarcinoma

The ASCO Post Staff  /  May 10, 2021

On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. CheckMate 649 The efficacy...

Patrizia Cavazzoni, MD, Named Director of the FDA’s Center for Drug Evaluation and Research

The ASCO Post Staff  /  May 10, 2021

On April 12, Patrizia Cavazzoni, MD, was announced as the Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA).  Janet Woodcock, MD, Acting Commissioner of the FDA, noted on Twitter: “Pleased to announce the permanent appointment of Patrizia ...

Kidney Cancer

FDA Approves Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma

The ASCO Post Staff  /  April 25, 2021

On March 10, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. TIVO-3 Efficacy was evaluated in TIVO-3 (ClinicalTrials.gov identi...

Gastroesophageal Cancer
Immunotherapy

FDA Approves Pembrolizumab Combination for Advanced Esophageal or Gastroesophageal Junction Carcinoma

The ASCO Post Staff  /  April 25, 2021

On March 22, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1–5 cm above the gastroesoph...

Multiple Myeloma
Immunotherapy

FDA Approves Idecabtagene Vicleucel for Heavily Pretreated Patients With Multiple Myeloma

The ASCO Post Staff  /  April 25, 2021

On March 26, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 ...

Lung Cancer

FDA Approves Lorlatinib for Metastatic ALK-Positive NSCLC

The ASCO Post Staff  /  April 10, 2021

On March 3, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. The FDA also approved the Ventan...

Lung Cancer

FDA Approves Cemiplimab-rwlc for Patients With NSCLC and High PD-L1 Expression

The ASCO Post Staff  /  March 25, 2021

On February 22, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) 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 [TPS] > 50%) as determined by an FDA-approved te...

Lymphoma
Immunotherapy

FDA Grants Accelerated Approval to Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma

The ASCO Post Staff  /  March 25, 2021

On March 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (Yescarta) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. ZUMA-5 Approval in follicular lymphoma was based on a single-ar...

Gastrointestinal Cancer

Novel Therapies and New Indications for Use in the Treatment of Gastrointestinal Cancers

The ASCO Post Staff  /  March 25, 2021 - Supplement: Gastrointestinal Oncology Almanac

The past year has witnessed the U.S. Food and Drug Administration (FDA) approval of a number of novel drugs and new indications for treating patients with gastrointestinal malignancies. A summary of these approvals is provided herein. Nivolumab plus ipilimumab: On March 10, 2020, the FDA granted ac...

Lung Cancer
Symptom Management

FDA Approves Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression in Adults Being Treated for SCLC

The ASCO Post Staff  /  March 10, 2021

On February 12, the U.S. Food and Drug Administration (FDA) approved trilaciclib (Cosela) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (SCLC). Tri...

Lymphoma

FDA Grants Accelerated Approval to Umbralisib for Treatment of Marginal Zone and Follicular Lymphomas

The ASCO Post Staff  /  March 10, 2021

On February 5, the U.S. Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq), a kinase inhibitor including PI3K-delta and CK1-epsilon, for the following indications: Adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior ...

Lymphoma
Immunotherapy

Lisocabtagene Maraleucel Approved by FDA for Patients With Relapsed or Refractory Large B-Cell Lymphoma

The ASCO Post Staff  /  March 10, 2021

On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi) for the treatment of 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 otherwi...

Skin Cancer

FDA Approves Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma

The ASCO Post Staff  /  March 10, 2021

On February 9, the U.S. Food and Drug Administration (FDA) granted regular approval to cemiplimab-rwlc (Libtayo) for patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. The FDA also granted accele...

Lung Cancer

FDA Grants Accelerated Approval to Tepotinib for Patients With Metastatic NSCLC and MET Exon 14–Skipping Alterations

The ASCO Post Staff  /  February 25, 2021

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 demonstrat...

Hematologic Malignancies
Immunotherapy

FDA Grants Accelerated Approval to Daratumumab Plus Hyaluronidase-fihj for Newly Diagnosed Light Chain Amyloidosis

The ASCO Post Staff  /  February 10, 2021

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...

Kidney Cancer
Immunotherapy

FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma

The ASCO Post Staff  /  February 10, 2021

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...

Prostate Cancer

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

The ASCO Post Staff  /  January 25, 2021

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...

Breast Cancer
Immunotherapy

FDA Approves Margetuximab-cmkb Plus Chemotherapy for Previously Treated Patients With Metastatic HER2-Positive Breast Cancer

The ASCO Post Staff  /  January 25, 2021

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...

Lymphoma

FDA Approves Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive ALCL

The ASCO Post Staff  /  January 25, 2021

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 ...

Multiple Myeloma

FDA Approves Selinexor for Refractory or Relapsed Multiple Myeloma

The ASCO Post Staff  /  January 25, 2021

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...

Immunotherapy
Leukemia
Lymphoma

FDA Approves Rituximab-arrx, a Biosimilar to Rituximab

The ASCO Post Staff  /  January 25, 2021

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  /  December 25, 2020

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 ...

COVID-19

FDA Authorizes Antigen Test as First Over-the-Counter, Fully At-Home Diagnostic Test for COVID-19

The ASCO Post Staff  /  December 25, 2020

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...

COVID-19

FDA Issues Emergency Use Authorization for First COVID-19 Vaccine

The ASCO Post Staff  /  December 25, 2020

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...

COVID-19

FDA Issues Emergency Use Authorization for First COVID-19 Test for Self-Testing at Home

The ASCO Post Staff  /  December 10, 2020

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...

Prostate Cancer

FDA Approves Gallium-68 PSMA-11 for PSMA-Targeted PET Imaging in Prostate Cancer

The ASCO Post Staff  /  December 10, 2020

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  /  November 25, 2020

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...

Leukemia

Venetoclax Combination in Newly Diagnosed AML

The ASCO Post Staff  /  November 25, 2020 - Supplement: Hematologic Oncology Almanac

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...

Leukemia
Geriatric Oncology

FDA Approves Venetoclax Combination Regimen for Certain Adult Patients With AML

The ASCO Post Staff  /  November 10, 2020

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 ...

COVID-19

FDA Approves Remdesivir for Patients With COVID-19 Requiring Hospitalization

The ASCO Post Staff  /  November 10, 2020

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...

Lymphoma
Immunotherapy

FDA Extends the Approval of Pembrolizumab for Patients With Classical Hodgkin Lymphoma

The ASCO Post Staff  /  November 10, 2020

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...

Breast Cancer
Lung Cancer
Gynecologic Cancers

FDA Approves Companion Diagnostic for Three Targeted Therapies for Advanced Ovarian, Breast, and Non–Small Cell Lung Cancers

The ASCO Post Staff  /  November 10, 2020

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...

Solid Tumors

Companion Diagnostic to Identify NTRK Fusions in Patients With Solid Tumors Eligible for Larotrectinib Treatment Approved by FDA

The ASCO Post Staff  /  November 10, 2020

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...

Lung Cancer
Immunotherapy

FDA Approves Nivolumab Plus Ipilimumab for the First-Line Treatment of Unresectable Malignant Pleural Mesothelioma

The ASCO Post Staff  /  October 25, 2020

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...

Breast Cancer

Novel Indications and New Drugs for the Treatment of Patients With Breast Cancer

The ASCO Post Staff  /  October 10, 2020 - Supplement: Breast Almanac

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...

Leukemia

FDA Approves Oral Azacitidine as Maintenance Therapy for Adults With AML in First Remission

The ASCO Post Staff  /  September 25, 2020

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...

Multiple Myeloma
Immunotherapy

FDA Approves Daratumumab Plus Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma

The ASCO Post Staff  /  September 10, 2020

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...

Skin Cancer
Immunotherapy

FDA Approves Atezolizumab Plus Cobimetinib/Vemurafenib for Advanced BRAF V600–Mutated Melanoma

The ASCO Post Staff  /  August 25, 2020

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....

Multiple Myeloma
Immunotherapy

FDA Grants Accelerated Approval to Belantamab Mafodotin-blmf for Pretreated Patients With Relapsed or Refractory Multiple Myeloma

The ASCO Post Staff  /  August 25, 2020

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...

Lymphoma
Immunotherapy

FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma

The ASCO Post Staff  /  August 10, 2020

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...

Solid Tumors
Immunotherapy

FDA Approves Pembrolizumab for Adults and Children With Tumor Mutational Burden–High Solid Tumors

The ASCO Post Staff  /  August 10, 2020

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 ...

Myelodysplastic Syndromes

FDA Approves Oral Combination of Decitabine and Cedazuridine for Adult Patients With Myelodysplastic Syndromes

The ASCO Post Staff  /  July 25, 2020

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...

Bladder Cancer
Immunotherapy

FDA Approves Maintenance Avelumab for the Treatment of Advanced Urothelial Carcinoma

The ASCO Post Staff  /  July 25, 2020

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...

Leukemia
Immunotherapy

FDA Extends Indication of Gemtuzumab Ozogamicin for Pediatric Patients With CD33-Positive AML

The ASCO Post Staff  /  July 10, 2020

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...

Lung Cancer

FDA Grants Accelerated Approval to Lurbinectedin for Metastatic SCLC

The ASCO Post Staff  /  July 10, 2020

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...

COVID-19

FDA Collaborating on Use of Real-World Data to Inform COVID-19 Response Effort

The ASCO Post Staff  /  July 10, 2020

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...

Colorectal Cancer
Immunotherapy

FDA Approves Pembrolizumab for the First-Line Treatment of MSI-H/dMMR Colorectal Cancer

The ASCO Post Staff  /  July 10, 2020

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...

Lymphoma

FDA Approves Selinexor for Relapsed or Refractory DLBCL

The ASCO Post Staff  /  July 10, 2020

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...

Breast Cancer
Immunotherapy

FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-Positive Breast Cancer

The ASCO Post Staff  /  July 10, 2020

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 ...

Lymphoma

FDA Grants Accelerated Approval to Tazemetostat for Some Patients With Follicular Lymphoma

The ASCO Post Staff  /  July 10, 2020

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...

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