FDA News

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.

The FDA granted a regular approval to sacituzumab govitecan (Trodelvy) for previously treated patients with unresectable locally advanced or metastatic triple-negative breast cancer.

The FDA has approved a new biweekly dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

The FDA has approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received 1 to 3 lines of therapy.

The FDA has granted a fast track designation for annamycin as a treatment for patients with soft tissue sarcoma lung metastases.

The FDA has approved a revised label for daunorubicin/cytarabine (Vyxeos) to include the treatment of pediatric patients aged 1 year and older with newly diagnosed, therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.

Ahead of the Prescription Drug User Fee Act action date for the application, the regulatory agency’s Oncologic Drugs Advisory Committee voted 10 to 0 that a decision be deferred until further findings from KEYNOTE-522 trial become available.

The FDA has granted 2 breakthrough device designations to cover new intended uses of the Signatera molecular residual disease (MRD) test.

The FDA has approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation.

The FDA has approved TheraSphere™ Yttrium-90 Glass Microsphere for the treatment of patients with hepatocellular carcinoma.

The FDA has granted priority review to the new drug application for the HIF-2α inhibitor belzutifan for the potential treatment of patients with von Hippel-Lindau–associated renal cell carcinoma that does not require immediate surgery.

Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.

The FDA has approved the VENTANA ALK CDx assay as a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer who are eligible to receive treatment with lorlatinib.

The FDA has granted priority review to the new drug application for the novel compound pafolacianine sodium injection for use in the identification of ovarian cancer during surgery.

The FDA expanded the indication for lorlatinib to include the front-line treatment of patients with ALK-positive non–small cell lung cancer.

The FDA approved melphalan flufenamide (Pepaxto; melflufen) plus dexamethasone for adults with triple-refractory multiple myeloma.

The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma with variant allele frequency of 20% or higher following progressive disease on platinum-based chemotherapy.

The FDA has approved the PD-L1 IHC 22C3 pharmDx assay, developed by Agilent Technologies Inc, for expanded use in patients with non–small cell lung cancer.

The FDA approved single-agent frontline cemiplimab-rwlc (Libtayo) for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a PD-L1 expression of 50% or greater.

The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

The FDA has granted priority review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, after at least 1 previous systemic therapy.

The FDA has approved trilaciclib to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.

The FDA approved cemiplimab-rwlc as the first immunotherapy for use in patients with advanced basal cell carcinoma that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.

The FDA approved umbralisib for the treatment of adults with relapsed/refractory marginal zone lymphoma and adults with relapsed/refractory follicular lymphoma.

The FDA has approved lisocabtagene maraleucel for adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.