New Drugs and Expanded Indications

MSHO will periodically provide information about newly approved therapies for cancer patients by the FDA and/or pharmaceutical updates to current therapies. This provides oncologists, hematologists, and professionals in oncology-related fields about recent approvals in a timely manner. Included will be a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety. In providing this information, MSHO does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

To view current and resolved drug shortages and discontinuations reported to FDA click here. 

12/05/2024

FDA Approves AstraZeneca's Imfinzi (Durvalumab) as First and Only Immunotherapy Regimen for Patients With Limited-Stage Small Cell Lung Cancer

11/21/2024

FDA Approves Jazz Pharmaceutical's Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)

11/18/2024

FDA Approves Syndax's Revuforj® (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation

10/31/2024

FDA Approves Novartis' Scemblix® For Adult Patients With Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP)

10/25/2024

FDA Approves Astellas' VYLOY™ (zolbetuximab-clzb) for Treatment of Advanced Gastric and GEJ Cancer

10/18/2024

FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

10/11/2024

FDA Approves Pfizer’s HYMPAVZI™ (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors

10/04/2024

FDA Approves Bristol Myers Squibb's Opdivo ® (nivolumab) for the Treatment of Adult Patients With Resectable (Tumors ≥4 cm or Node Positive) Non-Small Cell Lung Cancer (NSCLC)

09/26/2024

FDA Approves AstraZeneca’s Tagrisso (osimertinib) for the Treatment of Adult Patients With Unresectable, Stage III Epidermal Growth Factor Receptor-Mutated (EGFRm) Non-Small Cell Lung Cancer (NSCLC)

09/23/2024

FDA Approves Sanofi's Sarclisa (isatuximab) as the 1st Anti-CD38 Therapy in Combination W/ Standard-of-Care Treatment for Adult Patients W/ Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

09/20/2024

FDA Approves Johnson & Johnson's RYBREVANT® (amivantamab-vmjw) with Carboplatin and Pemetrexed for Adult Patients With Certain Types of Locally Advanced or Metastatic Non-Small Cell Lung Cancer

09/18/2024

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Platinum Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Advanced or Metastatic MPM

09/17/2024

FDA Approves Novartis' Kisqali® (ribociclib) in Combination With an Aromatase Inhibitor (AI) to Reduce Risk of Recurrence in People With HR+/HER2- Early Breast Cancer

09/13/2024

FDA Approves Genentech’s Tecentriq Hybreza, the First and Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

08/20/2024

FDA Approved Johnson & Johnson's RYBREVANT® (amivantamab-vmjw) Plus LAZCLUZE™ (lazertinib) as a First-Line Chemotherapy-Free Treatment for Patients with EGFR-Mutated Advanced Lung Cancer

08/19/2024

FDA Approved AstraZeneca's Imfinzi (durvalumab) for the Treatment of Resectable Non-Small Cell Lung Cancer Before and After Surgery

08/15/2024

FDA Approved Incyte & Syndax's Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD)

08/09/2024

FDA Approved Servier's VORANIGO®, an Isocitrate Dehydrogenase-1 (IDH1) & Isocitrate Dehydrogenase-2 (IDH2) Inhibitor for Patients 12 Years & Older With Grade 2 Astrocytoma or Oligodendroglioma

Therapies

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