FDA Approves Zanubrutinib for CLL or SLL

On January 19, 2023, the U.S Food and Drug Administration (FDA) approved zanubrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

For more information, read the FDA announcement and the Beigene announcement. 

Posted 1/20/2023

FDA Approves Cemiplimab + Chemotherapy for NSCLC

On November 8, 2022, the U.S Food and Drug Administration (FDA) approved cemiplimab-rwlc in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.

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

Posted 11/9/2022

GSK Shares Plans to Voluntarily Withdraw Niraparib

GlaxoSmithKline (GSK) is planning to voluntarily withdraw the indication of niraparib for treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status.

For more information read the GSK letter.

Posted 9/7/2022

CMS Delays Radiation Oncology Model For Further Rulemaking

On August 29, 2022, the Centers for Medicare & Medicaid Services (CMS) published a final rule (CMS-5527-F2) that finalized delaying the Radiation Oncology Model start date until a date is determined through future rulemaking.

For more information, visit the Radiation Oncology Model website.

Posted 8/30/2022

FDA Approves Ibrutinib for Pediatric Patients with Chronic Graft-Versus-Host Disease

On August 24, 2022, the U.S  Food and Drug Administration (FDA) approved ibrutinib for the treatment of pediatric patients one year and older with chronic graft-versus-host disease after failure of one or more lines of systemic therapy. 

For more information, read the FDA announcement. 

Posted 8/25/2022

FDA Approves Capmatinib for Metastatic NSCLC

On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

For more information, read the FDA announcement.

Posted 8/15/2022

Important Update: Olaparib in 4th Line Treatment of Ovarian Cancer

FDA Approves Tablet Formulation of Acalabrutinib

On August 5, 2022, the Food and Drug Administration approved new tablet formulation of acalabrutinib (Calquence, AstraZeneca) under accelerated approval based on overall response rate for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and patients with relapsed or refractory mantle cell lymphoma.

Read full press release. 

Posted on 08/05/2022

BMS Launches DDiCT Initiative to Improve Healthcare Outcomes for People with Disabilities

FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor