FDA News

The FDA has green lit mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with an EGFR exon 20 insertion mutation.

Zanubrutinib received an accelerated approval for the indication of adults with marginal zone lymphoma with at least 1 prior treatment with an anti-CD20-based therapy.

Zanubrutinib (Brukinsa) is now FDA approved for the treatment of adults with Waldenström Macroglobulinemia.

Pembrolizumab has been granted full approval as a first-line treatment for a select population of patients with bladder cancer.

The Food and Drug Administration approved adjuvant nivolumab to treat urothelial carcinoma in patients who are at high risk of recurrence after undergoing radical resection, irrespective of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

The regulatory decision is based on findings from collective data from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumor, non-endometrial cancer, cohort F of the ongoing phase 1 GARNET trial (NCT02715284).

Belzutifan, a hypoxia-inducible factor inhibitor, has been approved for treatment of adults with cancers related to von Hippel-Lindau disease.

The FDA has determined that more data are necessary to certify the clinical benefit of retifanlimab for the treatment of squamous cell carcinoma of the anal canal.

The FDA has approved the first immunotherapy, pembrolizumab (Keytruda), to treat patients with high-risk early-stage triple-negative breast cancer.

The FDA approval of daratumumab plus hyaluronidase-fihj (Darzalex Faspro) plus pomalidomide and dexamethasone (Pd) was supported by data from the APOLLO trial.

“For the first time, physicians can treat advanced urothelial cancer following treatment with a platinum-containing therapy and immunotherapy using an FDA-approved therapy that has demonstrated an OS benefit compared with chemotherapy.”

The Food and Drug Administration has approved pembrolizumab for the treatment of patients with a locally advanced form of skin cancer.

The FDA has approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) as a complement of treatment for the most common childhood cancer.

177Lu-PSMA-617 receives a breakthrough therapy designation to treat patients with metastatic castration-resistant prostate cancer.

Gunagratinib (ICP-192), a potential therapeutic option for patients with cholangiocarcinoma, has been granted an orphan drug designation by the FDA.

The FDA granted a priority review for a Biologics License Application (BLA) to bastilimab for the treatment of recurrent or metastatic cervical cancer.

The FDA approved avapritinib (Ayvakit) for the treatment of adults with advanced systemic mastocytosis (AdvSM), including those with mast cell leukemia (MCL), aggressive systemic mastocytosism (ASM), or systemic mastocytosis with an associated hematological neoplasm (SM-AHN).

The FDA approved injectable technetium Tc 99m tilmanocept (Lymphoseek), a radiopharmaceutical agent that targets lymphatic mapping and guiding for sentinel lymph node biopsies (SLNB), for use in pediatric patients with melanoma, rhabdomyosarcoma, and other solid tumors.

The FDA has accepted the biologics license application for a proposed biosimilar for pegfilgrastim, which had been developed by Lupin Limited.

The FDA has granted a breakthrough therapy designation to teclistamab for the treatment of patients with relapsed/refractory multiple myeloma.

Sotorasib is the first targeted therapy approved for KRAS-mutant non-small cell lung cancer.

The FDA has granted priority review to the biologics license application for ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma.

The FDA has approved piflufolastat F 18 injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer.

The FDA has accepted a biologics license application for ublituximab in combination with umbralisib in the treatment of patients with chronic lymphocytic leukemia and small lymphocytic leukemia.

The FDA has accepted a new drug application for maribavir for the treatment of post-transplant recipients with cytomegalovirus infection who are refractory and/or resistant to previous anti-CMV treatment.

This is the first targeted therapy regimen approved for this patient population.

The FDA approved adjuvant nivolumab for the treatment of patients with resected esophageal or gastroesophageal (GEJ) cancer who have previously had neoadjuvant chemoradiation treatment.

The FDA has approved pegcetacoplan (Empaveli) for the treatment of adults with paroxysmal nocturnal hemoglobinuria who are treatment naïve and those who are switching from the C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris).