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FDA Update

Hematologic Malignancies

FDA Approves Avapritinib for Advanced Systemic Mastocytosis

The ASCO Post Staff  /  July 10, 2021

On June 16, the U.S. Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor avapritinib (Ayvakit) for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and ma...

Hepatobiliary Cancer
Genomics/Genetics

FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma With an FGFR2 Fusion or Rearrangement

The ASCO Post Staff  /  June 25, 2021

On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor infigratinib (Truseltiq) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or ...

Lung Cancer
Genomics/Genetics

FDA Approves Sotorasib for KRAS G12C–Mutated NSCLC

The ASCO Post Staff  /  June 25, 2021

On May 28, the U.S. Food and Drug Administration (FDA) approved sotorasib (Lumakras) as the first treatment for adult patients with non–small cell lung cancer (NSCLC) whose tumors have a KRAS G12C genetic mutation and who have received at least one prior systemic therapy. This is the first approved ...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Grants Accelerated Approval to Pembrolizumab Combination for HER2-Positive Gastric Cancer

The ASCO Post Staff  /  June 10, 2021

On May 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-po...

Lung Cancer
Genomics/Genetics

FDA Grants Accelerated Approval to Amivantamab-vmjw for Metastatic EGFR Exon 20 Insertion–Mutated NSCLC

The ASCO Post Staff  /  June 10, 2021

On May 21, the U.S. Food and Drug Administration (FDA) granted accelerated approval to amivantamab-vmjw (Rybrevant), a bispecific antibody directed against epidermal growth factor and MET receptors, for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) and epiderm...

Prostate Cancer

FDA Approves Piflufolastat F-18 Injection, a PSMA PET Imaging Agent, for the Detection of Metastatic or Recurrent Prostate Cancer

The ASCO Post Staff  /  June 10, 2021

On May 27, the U.S. Food and Drug Administration (FDA) approved piflufolastat F-18 injection (Pylarify), an F-18–labeled prostate-specific membrane antigen (PSMA)-targeted positron-emission tomography (PET) imaging agent, to identify suspected metastasis or recurrence of prostate cancer. This is the...

Gastroesophageal Cancer
Immunotherapy

FDA Approves Nivolumab for Resected Esophageal or Gastroesophageal Junction Cancer

The ASCO Post Staff  /  June 10, 2021

On May 20, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. CheckMate 577 Efficacy was evaluated in CheckMat...

Breast Cancer
Immunotherapy

FDA Grants Regular Approval to Sacituzumab Govitecan-hziy for Pretreated Patients With Triple-Negative Breast Cancer

The ASCO Post Staff  /  May 25, 2021

On April 7, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for...

Bladder Cancer
Immunotherapy

FDA Grants Accelerated Approval to Sacituzumab Govitecan-hziy for Advanced Urothelial Cancer

The ASCO Post Staff  /  May 25, 2021

On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. TR...

Colorectal Cancer
Head and Neck Cancer

FDA Approves New Dosing Regimen for Cetuximab in Colorectal Cancer, Head and Neck Cancer

The ASCO Post Staff  /  May 25, 2021

On April 6, the U.S. Food and Drug Administration (FDA) approved a new dosage regimen for cetuximab (Erbitux) of 500 mg/m2 as a 120-minute intravenous infusion every 2 weeks for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck. This appr...

Lymphoma
Immunotherapy

FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for Large B-Cell Lymphoma

The ASCO Post Staff  /  May 25, 2021

On April 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta), 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, ...

Multiple Myeloma
Immunotherapy

FDA Approves Isatuximab-irfc Combination for Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  May 25, 2021

On March 31, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) 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. IKEMA 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 Patrizi...

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 effica...

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 ...

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...

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...

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

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...

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...

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...

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 ...

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...

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...

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...

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...

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...

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...

FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML

The ASCO Post  /  December 25, 2017

On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). Approval was based on data from an open-label, rand...

Solid Tumors
Kidney Cancer

FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma

The ASCO Post  /  December 25, 2017

On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular -approval to cabozantinib -(Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have receiv...

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