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

FDA Approves Pemigatinib for MLNs with FGFR1 Rearrangement

On August 26, 2022, the U.S Food and Drug Administration (FDA) approved pemigatinib for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

For more information, read the FDA announcement. 

Posted 8/30/2022

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 Approvees Fam-Trastuzumab Deruxtecan-nxki for HER2-Mutant NSCLC

On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

For more information, read the FDA announcement or the AstraZeneca and Daiichi Sankyo announcement.

Posted 8/15/2022

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

FDA Approves New Acalabrutinib Formulation

On August 5, 2022, the U.S. Food and Drug Administration approved the new tablet formulation for acalabrutinib for all current indications, including chronic lymphocytic leukaemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.

For more information, read AstraZeneca's announcement.

Posted 8/12/2022

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

FDA Approves Darolutamide + Docetaxel for mHSPC

On August 5, 2022, the U.S Food and Drug Administration (FDA) approved a supplemental new drug application for darolutamide in combination with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

For more information read the FDA announcement and the Bayer announcement. 

Posted 8/8/2022

FDA Approves Fam-Trastuzumab-Deruxtecan-nxki for HER2-Low Breast Cancer

On August 5, 2022, the U.S Food and Drug Administration (FDA) approved fam-trastuzumab-deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-low breast cancer.

For more information, read the FDA announcement .

Posted 8/5/2022