FDA News

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 the use of lisocabtagene maraleucel in patients with relapsed/refractory marginal zone lymphoma.

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 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.

Subcutaneous pembrolizumab has been approved across all indications, cutting chair and administration times with a median injection time of 2 minutes.

When treating patients with bladder cancer using gemcitabine intravesical system, regular AE monitoring is necessary, said Gary Steinberg, MD.

Relacorilant’s new drug application for platinum-resistant ovarian cancer has been accepted by the FDA.

Formerly known as TAR-200, gemcitabine intravesical system has received the FDA’s approval for use in patients with BCG-unresponsive NMIBC.

FDA accelerated approval was given to zongertinib for the treatment of patients with unresectable/metastatic nonsquamous NSCLC with HER2 TKD activating mutations.

The FDA has granted accelerated approval to dordaviprone for use in adult and pediatric patients with H3 K27M-mutated diffuse midline glioma.