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FDA Update

Leukemia
Genomics/Genetics

FDA Approves Asciminib for Philadelphia Chromosome–Positive CML

The ASCO Post Staff  /  November 25, 2021

On October 29, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor asciminib (Scemblix) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with two or more tyrosine kinas...

COVID-19

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children Aged 5 Through 11 Years

The ASCO Post Staff  /  November 25, 2021

On October 29, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include children aged 5 through 11 years. The authorization was based on the FDA’s thorough and transparent evaluation of the data that in...

Breast Cancer

FDA Approves Abemaciclib in Combination With Endocrine Therapy for Early Breast Cancer

The ASCO Post Staff  /  November 10, 2021

On October 12, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive early breast cancer wh...

Lung Cancer
Immunotherapy

FDA Approves Atezolizumab as Adjuvant Treatment for NSCLC

The ASCO Post Staff  /  November 10, 2021

On October 15, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as d...

Leukemia
Immunotherapy

FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL

The ASCO Post Staff  /  November 10, 2021

On October 1, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ZUMA-3 Efficacy was evaluate...

Gynecologic Cancers
Immunotherapy

FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer

The ASCO Post Staff  /  November 10, 2021

On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as determ...

Colorectal Cancer

FDA Expands Cetuximab Label for Encorafenib Combination in BRAF V600E Mutation–Positive Metastatic Colorectal Cancer

The ASCO Post Staff  /  October 25, 2021

The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for the EGFR inhibitor cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adults with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test, aft...

FDA Grants Accelerated Approval to Mobocertinib for Patients With Metastatic NSCLC and EGFR Exon 20 Insertion Mutations

The ASCO Post Staff  /  October 25, 2021

� On September 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mobocertinib (Exkivity) for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations (as detected by an FDA-approved test) whose disease has progr...

Breast Cancer

Recent FDA Approvals in Breast Cancer

The ASCO Post Staff  /  October 10, 2021 - Supplement: Breast Cancer Almanac

In the past year, the U.S. Food and Drug Administration (FDA) approved five treatment options for patients with breast cancer, which are summarized herein. Abemaciclib Combination On October 12, 2021, the FDA approved abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase inhibit...

Lymphoma

FDA Grants Zanubrutinib Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma

The ASCO Post Staff  /  October 10, 2021

On September 15, zanubrutinib (Brukinsa), a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK), received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one...

COVID-19

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

The ASCO Post Staff  /  October 10, 2021

The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for the use of a single booster dose to be administered at least 6 months after completion of the primary series in individuals aged 65 years and older; ind...

Thyroid Cancer

FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer

The ASCO Post Staff  /  October 10, 2021

On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth f...

Hematologic Malignancies
Symptom Management

Ruxolitinib Granted FDA Approval for Chronic Graft-vs-Host Disease

The ASCO Post Staff  /  October 10, 2021

On September 22, the U.S. Food and Drug Administration approved ruxolitinib (Jakafi), a JAK inhibitor, for the treatment of chronic graft-vs-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older. REACH3 Efficacy was evalua...

Gynecologic Cancers
Immunotherapy

FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer

The ASCO Post Staff  /  October 10, 2021

On September 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a tissue factor–directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on ...

Breast Cancer
Immunotherapy

Update on U.S. Indication for Atezolizumab in PD-L1–Positive Metastatic Triple-Negative Breast Cancer

The ASCO Post Staff  /  September 25, 2021

Genentech, a member of the Roche Group, announced that it has made the decision to voluntarily withdraw the U.S. accelerated approval for atezolizumab (Tecentriq) in combination with nab-paclitaxel for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast ca...

Solid Tumors
Immunotherapy

FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors

The ASCO Post Staff  /  September 25, 2021

On August 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli), an anti–PD-1 antibody, for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, who have had disease progr...

Lymphoma

FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia

The ASCO Post Staff  /  September 25, 2021

On August 31, the U.S. Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa), a Bruton’s tyrosine kinase inhibitor, for adult patients with Waldenström’s macroglobulinemia. ASPEN Trial Zanubrutinib was investigated in ASPEN (ClinicalTrials.gov identifier: NCT03053440), a randomized, ...

Bladder Cancer
Immunotherapy

FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma

The ASCO Post Staff  /  September 25, 2021

On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label upda...

Hepatobiliary Cancer

FDA Approves Ivosidenib for Advanced or Metastatic IDH1-Mutated Cholangiocarcinoma

The ASCO Post Staff  /  September 10, 2021

On August 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo), a small-molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), for adult patients with previously treated locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved ...

COVID-19

FDA Grants Approval to the Pfizer-BioNTech COVID-19 Vaccine

The ASCO Post Staff  /  September 10, 2021

On August 23, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals aged 16 years and older. The vaccine also co...

Bladder Cancer
Immunotherapy

FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma

The ASCO Post Staff  /  September 10, 2021

On August 19, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant trea...

Kidney Cancer
Immunotherapy

FDA Approves Lenvatinib/Pembrolizumab for Advanced Renal Cell Carcinoma

The ASCO Post Staff  /  September 10, 2021

On August 10, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). CLEAR Trial The efficacy of this combination was investigated in CLEAR (...

Breast Cancer
Immunotherapy

FDA Approves Pembrolizumab in Combination for High-Risk, Early-Stage Triple-Negative Breast Cancer

The ASCO Post Staff  /  August 25, 2021

On July 26, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. The FDA also gran...

Multiple Myeloma
Immunotherapy

FDA Approves Daratumumab and Hyaluronidase-fihj With Pomalidomide and Dexamethasone for Pretreated Patients With Multiple Myeloma

The ASCO Post Staff  /  August 10, 2021

On July 9, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasom...

Hematologic Malignancies

FDA Approves Belumosudil for Chronic Graft-vs-Host Disease

The ASCO Post Staff  /  August 10, 2021

On July 16, the U.S. Food and Drug Administration (FDA) approved belumosudil (Rezurock), a kinase inhibitor, for adult and pediatric patients aged 12 years and older with chronic graft-vs-host disease after failure of at least two prior lines of systemic therapy. KD025-213 Efficacy was evaluated i...

Bladder Cancer
Immunotherapy

Enfortumab Vedotin-ejfv Granted Regular Approval in Treatment of Locally Advanced or Metastatic Urothelial Cancer

The ASCO Post Staff  /  August 10, 2021

On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platin...

Gynecologic Cancers
Immunotherapy

Pembrolizumab/Lenvatinib Granted Regular Approval for Advanced Endometrial Carcinoma

The ASCO Post Staff  /  August 10, 2021

On July 21, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR). These patients must have ...

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 ...

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