FDA News

The FDA has granted full approval to brexucabtagene autoleucel for relapsed/refractory mantle cell lymphoma based on ZUMA-2 data.

The FDA has granted Fast Track designation to the FRα-targeting ADC ZW191 as a potential treatment for patients with for platinum-resistant ovarian cancer.

The FDA approved the combination of relacorilant and nab-paclitaxel in platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.

The FDA has granted traditional approval to nivolumab in cHL after autologous HSCT and brentuximab vedotin and after 3 or more lines of therapy.

The FDA issued a complete response letter to retifanlimab due to inspection findings at a third-party facility.

Samantha Shenoy, NP, MSN, provides nursing guidance on teclistamab/subcutaneous daratumumab’s second-line approval in multiple myeloma.

Teclistamab plus daratumumab hyaluronidase-fihj has been approved for patients with relapsed/refractory multiple myeloma as part of the CNPV program.

Zongertinib has been granted accelerated approval in NSCLC harboring HER2 TKD mutations as part of the Commissioner’s National Priority Voucher pilot program.

The FDA has approved encorafenib plus cetuximab and fluorouracil-based chemotherapy in patients with BRAF V600E-positive metastatic colorectal cancer.

The FDA has approved a monthly dosing schedule for subcutaneous amivantamab in NSCLC following the first 4 weeks of treatment.

New clinical data highlight the impact of infusion timing on NSCLC survival, alongside updated ASCO guidelines and FDA RMAT status for inhaled KB707.

The FDA approved IV and subcutaneous pembrolizumab with paclitaxel with or without bevacizumab for patients with platinum-resistant ovarian cancers.

The FDA updated its safety labeling for capecitabine and 5-FU to reflect that patients with certain genetic variants risk severe or fatal toxicities.

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 treatment combination of T-DXd and pertuzumab was granted FDA approval in the first-line for unresectable or metastatic HER2-positive breast 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.