FDA News

The FDA has approved belumosudil for the treatment of patients aged 12 years and older with chronic graft-versus-host disease following failure of at least 2 prior lines of therapy.

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).

The FDA has granted a breakthrough device designation to the Avenda Health Focal Therapy System, a male “lumpectomy” product under development to treat patients with prostate cancer in office while preserving quality of life.

The FDA has granted a priority review to the supplemental new drug application for ivosidenib tablets as a treatment option for patients with previously treated, IDH1-mutant cholangiocarcinoma.

The FDA granted an accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

The rolling submission of a new drug application to the FDA for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors has been completed.

The FDA has granted an accelerated approval to loncastuximab tesirine for the treatment of adult patients with relapsed/refractory large B-cell lymphoma following 2 or more lines of systemic therapy.

The FDA approved dostarlimab (Jemperli) for the treatment of patients with recurrent or advanced endometrial cancer that progressed on or after platinum-containing chemotherapy and whose cancer is DNA mismatch repair deficient (dMMR), as determined by an FDA-approved test.

The FDA approved nivolumab (Opdivo) plus certain types of chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma.

The FDA has granted a rare pediatric disease designation to the p-STAT3 inhibitor WP1066 for the treatment of patients with ependymoma, a rare type of tumor that can develop in the brain or the spinal cord.

The FDA granted an accelerated approval to sacituzumab govitecan (Trodelvy) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously had a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

The FDA has authorized the marketing of the first device that utilizes artificial intelligence based on machine learning to help clinicians detect lesions like polyps or suspected tumors in the colon in real time during a colonoscopy.