FDA Approvals

FDA Approvals

FDA Approves Pembrolizumab in Combination for High-Risk, Early-Stage TNBC

The FDA approves pembrolizumab for high-risk, early-stage TNBC in combination with CT as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

The ASCO Post
FDA Grants Regular Approval to Pembrolizumab/Lenvatinib for Advanced Endometrial Carcinoma

The FDA approves pembrolizumab in combination with lenvatinib for patients with advanced endometrial carcinoma that is not MSI-H or dMMR who have disease progression following...

The ASCO Post
FDA Approves Belumosudil for Chronic Graft-vs-Host Disease

The FDA approves belumosudil for adult and pediatric patients aged 12 years and older with chronic GvHD after failure of at least two prior lines of systemic therapy.

The ASCO Post

FDA Grants Regular Approval to Enfortumab Vedotin-ejfv for Locally Advanced or Metastatic Urothelial Cancer

The FDA approved enfortumab vedotin-ejfv for adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing CT..

The ASCO Post
FDA Approves Expanded Indication for Pembrolizumab in Locally Advanced Cutaneous Squamous Cell Carcinoma

The FDA approves an expanded label for pembrolizumab, an anti–PD-1 agent, as monotherapy for patients with locally advanced cSCC that is not curable by surgery or radiation.

The ASCO Post
FDA Approves New Asparaginase Product for Leukemia

The FDA has approved a new version of asparaginase for use in children and adults who have developed hypersensitivity to asparaginase derived from Escherichia coli.

FDA Approves Avapritinib for Advanced Systemic Mastocytosis

The FDA approves the tyrosine kinase inhibitor avapritinib for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis...

The ASCO Post
FDA Approves New Pediatric Indication for Technetium Tc 99m Tilmanocept Injection

The Lymphoseek injection—a radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies—has been approved for pediatric use by the FDA.

The ASCO Post
FDA OKs First Targeted Therapy for Subset of Patients With NSCLC

The FDA approves amivantamab as the first targeted treatment for patients with NSCLC harboring epidermal growth factor receptor exon 20 insertion mutations.

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

The FDA approves amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC and EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease...

The ASCO Post
FDA OKs Nivolumab After Surgery for Esophageal or GEJ Cancer

The FDA approves the adjuvant use of nivolumab in patients with resected esophageal or GEJ cancer who have received neoadjuvant CRT and have residual pathological disease following surgery.

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

The FDA approves pembrolizumab in combination with trastuzumab plus fluoropyrimidine- and platinum-containing CT for the first-line treatment of patients with locally advanced unresectable or metas

The ASCO Post
FDA Clears IND Application for CAR-Natural Killer Cell Therapy to Treat B-Cell Malignancies

The FDA cleared an investigational new drug application for NKX019, a chimeric antigen receptor-natural killer cell therapy for patients with R/R B-cell malignancies.

FDA Panel Votes Against Two Cancer Indications But Backs 4 of 6


The staff of the FDA will now consider these votes as they decide what to do regarding the six cases of what they have termed "dangling" accelerated approvals.

FDA ODAC Votes in Favor of Maintaining Accelerated Approval of Atezolizumab/Nab-paclitaxel for PD-L1–Positive, Metastatic Triple-Negative Breast Cancer

The FDA ODAC voted seven to two in favor of maintaining accelerated approval of atezolizumab in combination with CT for the treatment of adults with unresectable locally advanced or metastatic TNBC

The ASCO Post
FDA Grants Breakthrough Therapy Designation to Asciminib for CML

The FDA has granted breakthrough therapy designation to asciminib for the treatment of adults with Philadelphia chromosome-positive chronic-phase CML that is resistant to...

ASH Clinical News
FDA Approves Loncastuximab for Diffuse Large B-Cell Lymphomas

The FDA grants an accelerated approval for a new drug for use in patients with R/R DLBCL who have tried at least two prior systemic therapies.

FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer

The FDA approved nivolumab as part of combination therapy for certain patients with gastrointestinal malignancies.

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

The FDA granted accelerated approval to sacituzumab govitecan-hziy for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing CT and...

The ASCO Post
CAR-T Therapy Is Approved for Non-Hodgkin Lymphoma

Lisocabtagene maraleucel is a CAR-T therapy indicated for patients who haven’t responded to or have relapsed after at least 2 other systemic treatments.

JAMA Network
FDA Updates Highlighting the Latest Cancer Treatments

Oncology Times covers the most recent FDA approvals in cancer treatment.

Oncology Times - Latest Articles
FDA Approves Pembrolizumab Combination for Advanced Esophageal or Gastroesophageal Junction Carcinoma

The FDA has approved pembrolizumab in combination with platinum and fluoropyrimidine-based CT for patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma...

The ASCO Post
FDA Updates Highlighting the Latest Cancer Treatments

The latest developments in FDA approvals for cancer treatments.

Oncology Times - Latest Articles
FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval

These products are being used under accelerated approval to treat patients with breast, urothelial, gastric, and hepatocellular cancers.

The ASCO Post
FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma

The FDA just granted accelerated approval to Pepaxto in combination with dexamethasone for adult patients with R/R multiple myeloma who have received at least four prior lines of therapy...

The ASCO Post
FDA OKs New CAR T- Cell Tx for Large B-cell Lymphomas

The FDA has approved lisocabtagene maraleucel (Breyanzi), a CAR T-cell product for the treatment of adults with certain types of R/R large B-cell lymphoma who relapse or...

FDA Updates Highlighting the Latest Cancer Treatments

Read more about the FDA's latest updates in cancer treatment.

Oncology Times - Latest Articles
FDA Updates Highlighting the Latest Cancer Treatments

The FDA approved margetuximab-cmkb in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received...

Oncology Times - Latest Articles
FDA Approves First and Only Treatment for AL Amyloidosis

The first and only treatment for a rare and often fatal blood cell disorder has been approved in the United States.

FOCR Meeting Highlights Modernization of Expedited FDA Drug Approvals

The Friends of Cancer Research held the first of a two-part virtual annual meeting, which focused on ways of updating expedited drug approvals at the FDA.

Oncology Times - Latest Articles
A New Strategy in Treating Patients With CAR T-Cell Therapy

A novel “switchable” CAR T-cell therapy for blood cancers moved into early clinical trials recently after gaining Fast Track designation from the FDA. 

Oncology Times - Latest Articles
FDA Approval of Immunotherapy Drugs Brings Hope to Mesothelioma Patients

The drugs—nivolumab and ipilimumab—have now been approved by the FDA for first-line treatment of adult patients who suffer from malignant pleural mesothelioma.

Oncology Times - Latest Articles

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