FDA News

Fast track designation has been granted by the FDA to vepdegestrant for the treatment of select patients with ER-positive/HER2-negative locally advanced or metastatic breast cancer.

FDA granted a fast-track designation to the TROP2-directed ADC BNT325/DB-1305 for the treatment of platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.

The FDA granted efineptakin alfa an orphan drug designation, deeming it a potential treatment option for pancreatic cancer.

A priority review has been granted by the FDA to trastuzumab deruxtecan for the treatment of unresectable or metastatic HER2-positive advanced solid tumors.

Erdafitinib was approved for the treatment of adults with locally advanced or metastatic urothelial carcinoma, which amends a previously approved indication of the drug.

Pembrolizumab plus chemoradiotherapy has been approved by the FDA for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer.

A supplemental biologics license application has been granted priority review by the FDA, which seeks a full approval of tisotumab vedotin for patients with recurrent or metastatic cervical cancer that progressed on or following frontline therapy.

The Food and Drug Administration approved an on-body delivery system for pegfilgrastim-cbqv, a biosimilar of pegfilgrastim.

In this special episode of The Vitals, we ring in the New Year 2024 by combing through 2023 FDA approvals.

The FDA has granted approval to enfortumab vedotin plus pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

The FDA has approved belzutifan to treat patients with advanced renal cell carcinoma (RCC) who have already undergone PD-1 or PD-L1 inhibitor and a VEGF tyrosine kinase inhibitor.

Eflornithine (Iwilfin) received FDA approval to reduce the risk for relapse in pediatric and adult patients with high-risk neuroblastoma, making it the first therapy to reduce risk for relapse in children with the disease.

A priority review of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma is underway.

The FDA has approved the non-covalent BTK inhibitor, pirtobrutinib, to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have already undergone 2 lines of therapy.

There have been reports of T-cell malignancies among patients who have undergone CD19- or BCMA-directed autologous CAR T-cell immunotherapies.

The FDA has approved nirogacestat as a treatment for adults with progressing desmoid tumors based off findings from the phase 3 DeFi trial.

The FDA has expanded the indication for enzalutamide to include patients with high-risk nonmetastatic castration-sensitive prostate cancer.

The FDA has approved capivasertib plus fulvestrant to treat patients with locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations.

The FDA has approved pembrolizumab plus chemotherapy to treat adults with locally advanced or metastatic, HER2-negative gastric cancers.

Repotrectinib is now available to treat adults with advanced or metastatic non-small cell lung cancer that harbors a ROS1 fusion.

The PD-L1 IHC 22C3 pharmDx diagnostic tool will help identify patients with gastric or gastroesophageal junction adenocarcinoma whose disease expresses PD-L1 and who are thereby eligible for pembrolizumab.

The FDA has restricted the indication for gastric cancer to only include patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.

Lisocabtagene maraleucel is under consideration as a potential treatment option for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA has approved fruquintinib to treat adults with metastatic colorectal cancer.

The FDA has approved pembrolizumab in combination with chemotherapy as a treatment for patients with locally advanced unresectable or metastatic biliary tract cancer.

The FDA has approved toripalimab, with cisplatin and gemcitabine, and as a monotherapy, to treat adults with nasopharyngeal carcinoma.

Ivosidenib, a targeted therapy, has been approved for patients with relapsed or refractory myelodysplastic syndromes and an IDH1 mutation.

The FDA has approved entrectinib to treat pediatric patients ages 1 month and older with NTRK-positive solid tumors.

The FDA has approved tests to identify patients with metastatic non–small cell lung cancer who are eligible for treatment with encorafenib plus binimetinib.

The FDA has granted priority view to osimertinib plus chemotherapy based on data from the phase 3 FLAURA2 trial.