FDA News

Dato-DXd has been given priority review for the treatment of patients with unresectable/metastatic triple-negative breast cancer.

The FDA approved a larger vial size of nelarabine for the treatment of pediatric and adult patients with T-ALL and T-LBL.

The FDA approved subcutaneous daratumumab/VRd in patients with newly diagnosed multiple myeloma who are not eligible for ASCT. Here’s what you should know.

The FDA granted JSKN003 breakthrough therapy status for gynecologic cancers based on data from the phase 1 JSKN003-101 and phase 1/2 JSKN003-102 trials.

Risvutatug rezetecan, an antibody-drug conjugate was granted FDA orphan drug designation for use in patients with small cell lung cancer.

Oncology nurses and APPs are key players in patient education on precision medicine.

Subcutaneous mosunetuzumab wins FDA accelerated approval in patients with R/R follicular lymphoma following 2 or more lines of systemic therapy.

The FDA has approved the use of subcutaneous amivantamab and hyaluronidase-lpuj across all amivantamab indications.

The FDA has greenlit treatment with rucaparib for previously treated patients with BRCA-mutated metastatic castration-resistant prostate cancer.

The FDA has approved niraparib and abiraterone acetate with prednisone for the treatment of patients with BRCA2-mutated metastatic hormone-sensitive prostate cancer.

The FDA has approved lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory marginal zone lymphoma following at least 2 prior lines of therapy.

The FDA has approved pirtobrutinib treatment for adults with relapsed/refractory CLL/SLL who have received prior treatment with a covalent BTK inhibitor.

Catch up on recent regulatory decisions by the FDA in oncology, including actions in lung, hematologic, genitourinary, and gastrointestinal cancers.

The FDA has approved durvalumab plus FLOT for the treatment of patients with resectable gastric or gastroesophageal junction adenocarcinoma.

The FDA has approved intravenous or subcutaneous pembrolizumab combined with enfortumab vedotin-ejfv in the neoadjuvant and adjuvant MIBC settings.

The FDA has converted its accelerated approval to a standard one for tarlatamab in extensive-stage small cell lung cancer.

The FDA has approved sevabertinib for the treatment of patients with HER2-positive nonsquamous non-small cell lung cancer.

The FDA granted standard approval to epcoritamab monotherapy and epcoritamab plus lenalidomide and rituximab for relapsed/refractory follicular lymphoma.

The FDA has approved a biosimilar of pertuzumab that is indicated for multiple breast cancer settings.

The FDA has approved ziftomenib for relapsed or refractory acute myeloid leukemia harboring NPM1 mutations with no alternative treatment options.

The FDA has approved subcutaneous daratumumab and hyaluronidase-fihj for use in patients with high-risk smoldering multiple myeloma.

The FDA has approved revumenib for relapsed or refractory NPM1-mutated acute myeloid leukemia.

BCMA-targeting ADC belantamab mafodotin was approved for use in patients with relapsed/refractory multiple myeloma after 2 or more lines of treatment.

Following imlunestrant’s approval, Komal Jhaveri, MD, FACP, compares the oral SERD to its counterpart, elacestrant, in terms of composition and trials.

The FDA has granted approval to adjuvant cemiplimab treatment for patients with high-risk cutaneous squamous cell carcinoma after surgery and radiation.

The FDA has approved lurbinectedin plus atezolizumab for the treatment of extensive-stage small cell lung cancer following induction therapy with atezolizumab.

The REMS program for vandetanib in the treatment of patients with medullary thyroid cancer has been removed by the FDA.

The FDA has approved imlunestrant for the treatment of patients with ESR1-mutated ER+, HER2- metastatic breast cancer.