FDA Receives BLA Resubmission for I-Omburtamab for CNS/Leptomeningeal Metastasis from Neuroblastoma
April 1st 2022For the second time, an application for approval has been submitted for the FDA for I-omburtamab for the treatment of pediatric patients with central nervous system or leptomeningeal metastasis from neuroblastoma.
FDA Grants Priority Review to Futibatinib for FGFR2+ Locally Advanced/Metastatic Cholangiocarcinoma
March 30th 2022The FDA has accepted for priority review a new drug application for futibatinib seeking approval for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma who harbor FGFR2 gene rearrangement, including gene fusions.
PP2A Inhibitions May Address Transformation of NSCLC to SCLC in Patients With EGFR+ Disease
March 29th 2022In an interview with Targeted Oncology, Ravi Salgia, MD, PhD, discussed the research leading to the first-in-human study of LB-100 combined with chemotherapy or immunotherapy to address transformation to small cell lung cancer.
Durvalumab Plus Chemoradiotherapy Does Not Extend PFS in Locally Advanced Cervical Cancer
March 28th 2022The phase 3 CALLA study did not achieve its key end point of progression-free survival improvement with the addition of durvalumab to chemoradiotherapy in patients with locally advanced cervical cancer.
Doctors Debate: Is PD-L1 Testing Necessary Before Starting ICI Therapy in Gastroesophageal Cancer?
March 28th 2022During a debate at the Gastrointestinal Cancers Symposium, Florian Lordick, MD, argued that knowledge of PD-L1 expression level was needed before starting immune checkpoint inhibitor therapy. He was challenged by Aaron James Scott, MD, who argued that knowledge of PD-L1 is not necessary before initiating immune checkpoint inhibitor therapy.
FDA Postpones Decision on Luspatercept-aamt for Anemia in Adults With NTD Beta Thalassemia
March 25th 2022The FDA is no longer conducting a speedy review of the supplemental biologics license application for luspatercept-aamt as treatment for anemia in adults with non-transfusion-dependent beta thalassemia.
FDA Denies Approval of Sintilimab With Chemotherapy for Nonsquamous NSCLC
March 24th 2022The FDA has issued a complete response letter denying approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy as frontline treatment for patients with nonsquamous non–small cell lung cancer.
FDA Approves Lu 177 Vipivotide Tetraxetan for Metastatic Castration-Resistant Prostate Cancer
March 23rd 2022The FDA has granted approval to the agent formerly known as 177Lu-PSMA-617 for the treatment of patients with metastatic castration-resistant prostate cancer in the post androgen receptor pathway inhibition, post-taxane-based chemotherapy setting.
Behind the FDA Approval: Adjuvant Olaparib for BRCA+/HER2- Breast Cancer
March 22nd 2022In an interview with Targeted Oncology, Charles Geyer, MD, discussed the data from the OlympiA clinical trial and how adjuvant olaparib could impact the treatment of BRCA-positive, HER2-negative breast cancer and other BRCA-positive women’s cancers.