FDA News

The FDA approved durvalumab plus BCG for high-risk NMIBC based on significant disease-free survival gains in the POTOMAC trial.

FDA approves pivekimab sunirine-pvzy for adults with BPDCN, offering a new CD123-directed therapy for this ultra-rare hematologic malignancy.

FDA approves datopotamab deruxtecan-dlnk for first-line metastatic TNBC, improving PFS, OS and response rates vs chemotherapy.

The FDA approved T-DXd for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer, showing improved pCR and IDFS rates.

FDA approves atezolizumab and a companion diagnostic for adjuvant treatment of MIBC in patients with detected circulating tumor DNA after surgery.

The FDA approved oral decitabine/cedazuridine and venetoclax for AML. Research showed a 41.6% complete remission rate in chemo-ineligible adults

The FDA approved sonrotoclax for R/R mantle cell lymphoma. Nurses must manage a 4-week dose ramp-up to prevent TLS for patients after prior BTK therapy.

Learn about the FDA approval of vepdegestrant (Veppanu), the first PROTAC for ESR1-mutated breast cancer, including nursing priorities and side effects.

FDA approved zenocutuzumab-zbco for post-systemic-therapy, NRG1 fusion–positive unresectable/metastatic cholangiocarcinoma, addressing an ultra-rare molecular subset with limited options.

FDA approves vepdegestrant for ER-positive, HER2-negative breast cancer. Learn key efficacy data, safety risks, and nursing care considerations.

FDA accepts Zanidatamab combo sBLA for HER2+ gastroesophageal cancer, showing improved outcomes in HERIZON-GEA-01 trial with priority review underway.

FDA grants Priority Review to enfortumab vedotin plus pembrolizumab in MIBC, showing improved survival and reduced recurrence risk in phase 3 EV-304 trial.

Alembic Pharmaceuticals receives FDA approval for Methotrexate Injection for patients with cancer.

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 acalabrutinib plus venetoclax in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

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.