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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
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FDA Approves Tremelimumab in Combination with Durvalumab for Unresectable HCC
On October 21, 2022, the U.S Food and Drug Administration (FDA) approved tremelimumab in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (HCC).
For more information, read the FDA announcement and the AstraZeneca announcement.
Posted 10/24/2022
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FDA Grants Accelerated Approval to Futibatinib for Cholangiocarcinoma
On September 30, 2022, the Food and Drug Administration (FDA) granted accelerated approval to futibatinib for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.
For more information read the FDA announcement.
Posted 10/3/2022
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FDA Expands Selpercatinib Approval for RET Fusion-Positive Solid Tumors
On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
For more information, read the FDA announcement and the Lilly announcement.
Posted 9/22/2022
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FDA Approves Durvalumab + Gemcitabine for Biliary Tract Cancer
On September 2, 2022, the U.S Food and Drug Administration (FDA) durvalumab in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.
For more information, read the FDA announcement, and the AstraZeneca announcement.
Posted 9/8/2022
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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
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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
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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
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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
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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