ONCOLOGY NEWSFEED

On December 12, the FDA approved niraparib and abiraterone acetate with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.

For more information, read the FDA announcement and visit the Janssen Biotech website .

On December 4, the FDA approved lisocabtagene maraleucel for adults with relapsed or refractory marginal zone lymphoma who have received at least 2 prior lines of systemic therapy.

For more information, read the FDA announcement and the Bristol Myers Squibb press release .

On December 3, the FDA granted traditional approval to pirtobrutinib for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor.

For more information, read the FDA announcement and the Lilly press release .

On November 25, the FDA approved durvalumab with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma.

For more information, read the FDA announcement and the AstraZeneca press release .

On November 21, the FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin.

For more information, read the FDA announcement and the Merck press release .

On November 19, the FDA granted traditional approval to tarlatamab-dlle for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

For more information, read the FDA announcement and the Amgen press release .

On November 19, the FDA granted accelerated approval to sevabertinib, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 ( ERBB2 ) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

For more information, read the FDA announcement and the Bayer press release .

On November 19, the FDA granted traditional approval to daratumumab and hyaluronidase-fihj with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis.

For more information, read the FDA announcement and visit the Janssen Biotech website .

On November 19, the FDA approved selumetinib for adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

For more information, read the FDA announcement and the AstraZeneca press release.

On November 18, the FDA approved epcoritamab-bysp with lenalidomide and rituximab for relapsed or refractory follicular lymphoma. The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after 2 or more lines of systemic therapy.

For more information, read the FDA announcement and the Genmab press release .

On November 13, the FDA approved pertuzumab-dpzb as an interchangeable biosimilar to pertuzumab.

For more information, read the FDA announcement and visit the Shanghai Henlius Biologics website .

The FDA approved ziftomenib for select adults with relapsed or refractory acute myeloid leukemia.

For more information, read the FDA announcement and the Kura Oncology press release .

On November 6, the FDA approved daratumumab and hyaluronidase-fihj for adults with high-risk smoldering multiple myeloma.

For more information, read the FDA announcement and the Janssen Biotech press release .

The FDA approved belantamab mafodotin-blmf, a B-cell maturation antigen-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

For more information, read the FDA announcement and the GlaxoSmithKline press release .

Eli Lilly and Company announced results from the primary overall survival analysis of the Phase 3 monarchE trial showing that 2 years of adjuvant abemaciclib plus endocrine therapy reduced the risk of death and resulted in sustained long-term improvements in invasive disease-free survival and distant relapse-free survival for select patients.

For more information, read the Eli Lilly press release .

The FDA approved cemiplimab-rwlc for the adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.

For more information, read the FDA announcement and the Regeneron Pharmaceuticals press release .

The FDA approved lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for the maintenance treatment of select adult patients with extensive-stage small cell lung cancer.

For more information, read the FDA announcement and the Jazz Pharmaceuticals press release .

The FDA approved imlunestrant for select adults with estrogen receptor-positive, human epidermal growth factor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer.

For more information, read the FDA announcement and the Eli Lilly and Company press release .

The FDA approved pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab.

For more information, read the FDA announcement and the Merck press release .

The FDA approved selumetinib granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

For more information, read the FDA announcement and visit the Koselugo website .

The FDA approved gemcitabine intravesical system for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

For more information, read the FDA announcement and the Janssen Biotech press release .

The FDA granted accelerated approval to zongertinib for select adults with unresectable or metastatic non-squamous non-small cell lung cancer.

For more information, read the FDA announcement and the Boehringer Ingelheim Pharmaceuticals press release .

The FDA granted accelerated approval to dordaviprone for select patients with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

For more information, read the FDA announcement and the Jazz Pharmaceuticals press release .

The FDA approved label updates for both of Bristol Myers Squibb's CAR T-cell therapies: lisocabtagene maraleucel and idecabtagene vicleucel.

For more information, read the Bristol Myers Squibb press release .