FDA Approvals

FDA Approvals

FDA Approves Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor​

The FDA approved sirolimus protein-bound particles for injectable suspension for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor. 

Oncology Times - Latest Articles
FDA Approves Keytruda for Adjuvant Treatment of Renal Cell Carcinoma

The FDA expanded the approval of pembrolizumab to include adjuvant treatment of certain patients with renal cell carcinoma.

FDA Grants Orphan Drug Designation to DF1001 for Esophageal Cancer

The FDA granted orphan drug designation to DF1001, a HER2-targeted natural killer cell engager therapy, for treatment of esophageal cancer.


FDA Nods for Adjuvant Pembrolizumab in Kidney Cancer

Pembrolizumab has been granted approval from the US FDA for use as an adjuvant treatment following surgery in certain patients with RCC, making it the first immunotherapy to have this indication.

FDA Approves Ropeginterferon Alfa-2b-Njft for Polycythemia Vera

The FDA approves ropeginterferon alfa-2b-njft, a monopegylated, long-acting interferon, for the treatment of adults with polycythemia vera.

FDA Grants Fast Track Designation to Bemcentinib for Advanced NSCLC

The FDA granted fast track designation to bemcentinib for treatment of certain patients with non-small cell lung cancer.

FDA Grants Fast Track Designation to TT-00420 for Cholangiocarcinoma

The FDA granted fast track designation to TT-00420 for treatment of patients with cholangiocarcinoma who have no standard therapy options.

FDA Grants Priority Review to Parsaclisib for Two Lymphoma Indications

The designations apply to use of the agent for treatment of adults with R/ RMZL who received at least one prior anti-CD-20-based regimen, as well as adults with MCL...

FDA Approves Asciminib for Philadelphia Chromosome–Positive CML

The FDA granted accelerated approval to asciminib for patients with Ph+ CML in chronic phases who have been previously treated with two or more tyrosine kinase inhibitors.

The ASCO Post
FDA Clears Application for Anti-PD-1 CAR-T to Treat Hematologic, Breast Cancers

The FDA clears investigational new drug application for PRGN-3007, a chimeric antigen receptor T-cell therapy for patients with advanced hematologic malignancies or solid tumors expressing ROR1.

Keytruda Approved as First-Line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer

The FDA approves keytruda in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1...

Cancer Therapy Advisor
FDA Approves Tecentriq for New Lung Cancer Indication

The FDA expanded the approval of atezolizumab to include adjuvant treatment of certain patients with NSCLC. 

FDA Approves Pembrolizumab Plus Chemo as First-Line Therapy for Advanced, Recurrent Cervical Cancer

The FDA has approved the checkpoint inhibitor pembrolizumab alongside standard chemotherapy, as first-line therapy for patients with PD-L1-expressing cervical cancer.

FDA Approves Verzenio for Certain Patients With Early Breast Cancer

The approval applies to use of the agent by adults with hormone receptor-positive, HER2-negative, node-positive disease at high risk for recurrence who have a Ki-67 score of at least 20%.

FDA Grants Breakthrough Device Designation to Alpha DaRT for Glioblastoma

Alpha DaRT is proposed as an adjunct to standard medical therapies for patients with glioblastoma multiforme or as standalone therapy for patients who have exhausted standard therapies.

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

The FDA approves brexucabtagene autoleucel, a CD19-directed CAR T-cell therapy, for adult patients with relapsed or refractory B-cell precursor ALL.

The ASCO Post
FDA Approves Erbitux With Braftovi for Colorectal Cancer Subset

The FDA approval is based on results of the randomized phase 3 BEACON CRC trial, which included patients with BRAF V600E-mutant mCRC that progressed after one or two prior regimens.

FDA Grants Orphan Drug Designation to Nadunolimab for Pancreatic Cancer

Nadunolimab (CAN04, Cantargia AB) is an IL1RAP-binding antibody in development for various types of cancer including pancreatic ductal adenocarcinoma.  

FDA Approves Cabozantinib for Differentiated Thyroid Cancer

The FDA approves Cabozantinib, indicated for patients whose disease has progressed after they have received VEGFR-targeted therapy...

FDA Grants Fast Track Designation to CAR Macrophage Cell Therapy for HER2-Positive Tumors

The FDA granted fast track designation to CT-0508 for treatment of patients with solid tumors that overexpress human epidermal growth factor receptor 2.

FDA Clears IND Application For CRISPR-Edited T-Cell Receptor Therapy to Treat AML

The FDA cleared an investigational new drug application for NTLA-5001, a T-cell receptor T-cell therapy designed to treat adults with relapsed or refractory acute myeloid leukemia.

FDA Approves Tivdak for Advanced Cervical Cancer

The FDA granted accelerated approval to tisotumab vedotin-tftv for certain women with advanced cervical cancer.

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

The FDA approves cabozantinib for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer...

The ASCO Post
FDA Approves First Oral Drug for NSCLC With EGFR Exon20 Insertion

The FDA grants accelerated approval to mobocertinib for the treatment of patients with locally advanced or metastatic non–small-cell lung cancer with EGFR exon 20 insertion mutations.

FDA Approval for Zanubrutinib in Waldenström’s Macroglobulinemia

The FDA has approved zanubrutinib capsules for use in the treatment of adult patients with Waldenström's macroglobulinemia.

FDA Grants Fast Track Designation to IN10018 For Ovarian Cancer

Preclinical and clinical data suggests the agent has promising efficacy when combined with standard chemotherapy for women with platinum-resistant ovarian cancer.

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

The FDA granted accelerated approval to dostarlimab-gxly for adult patients with mismatch repair–deficient recurrent or advanced solid tumors, as determined by an FDA-approved test...

The ASCO Post
FDA Grants Orphan Drug Designation to Allogeneic CAR-T for Advanced Multiple Myeloma


The FDA granted orphan drug designation to ALLO-715 for the treatment of advanced multiple myeloma.

FDA Approves Belzutifan for Cancers Associated With von Hippel-Lindau Disease

The FDA approves belzutifan for adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas, or pancreatic neuroendocrine tumors not requiring immediate surgery.

The ASCO Post
FDA Approves Lenvatinib/Pembrolizumab for Advanced Renal Cell Carcinoma

The FDA approves the combination of lenvatinib plus pembrolizumab for the first-line treatment of adult patients with advanced renal cell carcinoma.

The ASCO Post
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

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