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FDA to Review sBLA for Amivantamab Plus Chemo in EGFRm Advanced NSCLC
November 20th 2023Positive findings from the MARIPOSA-2 study of amivantamab with chemotherapy with or without lazertinib in locally advanced or metastatic non–small cell lung cancer with EGFR mutations support the submission of a supplemental biologics license application to the FDA.
DuMontier Discusses Frailty in Newly Diagnosed Multiple Myeloma
November 18th 2023Clark DuMontier, MD, discusses the main takeaways from his presentation on treatment intensity and frailty in newly diagnosed patients with multiple myeloma given at the 20th International Myeloma Society Annual Meeting.
FDA Greenlights Capivasertib/Fulvestrant in Breast Cancer With PIK3CA, AKT1, PTEN Alterations
November 17th 2023The FDA has approved capivasertib with fulvestrant for adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alterations.
FDA Approves Pembrolizumab/Chemo for Gastric and GEJ Adenocarcinoma
November 16th 2023Pembrolizumab and fluoropyrimidine- and platinum-containing chemotherapy are now FDA-approved for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA’s ODAC Confronts Issues With Accelerated Approval Program
November 16th 2023The FDA’s Oncologic Drugs Advisory Committee discussed delays that can occur when drugs are granted accelerated approval, and the post-approval confirmatory trials of pralatrexate and belinostat for peripheral T-cell lymphoma.
Maen Hussein: ‘Every Success Motivates Us to Do Even Better’
November 16th 2023In an interview with Targeted Oncology, Maen Hussein, MD, a Q3 2023 Oncology Icons honoree, discusses his path to the community oncology setting and highlights upcoming trends in oncology he feels will improve patient outcomes.
Monk on KEYNOTE-A18 Data of Pembro/Chemoradiotherapy in Cervical Cancer
November 15th 2023Bradley J. Monk, MD, FACS, FACOG, discusses the phase 3 KEYNOTE-A18 study of pembrolizumab with chemoradiotherapy for the treatment of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.
FDA to Review ProSense De Novo Request in Early-Stage Breast Cancer
November 15th 2023Following the FDA’s denial of a de novo classification request of ProSense, citing concerns about the choice of comparator group used in the ICE3 trial, IceCure is working to identify a more representative comparator group.