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. 

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

06/27/2024

FDA Approved Genmab's & Pharmacyclics' EPKINLY® (epcoritamab-bysp) for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

06/24/2024

FDA Granted Accelerated Approval of BMS / Mirati's KRAZATI® (adagrasib) in Combo with Cetuximab for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer

06/18/2024

FDA Approved Merck's KEYTRUDA® (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma

06/17/2024

FDA Approved Amgen's BLINCYTO® (blinatumomab) for Patients One Month or Older With CD19-Positive Philadelphia Chromosome-Negative B-ALL in the Consolidation Phase, Regardless of MRD Status

06/17/2024

FDA Approved AstraZeneca's Imfinzi (durvalumab) Plus Chemotherapy for Adult Patients With Primary Advanced or Recurrent Endometrial Cancer That is Mismatch Repair Deficient (dMMR)

06/14/2024

FDA Approved Bristol Myers Squibb's Augtyro (repotrectinib), a Next-Generation TKI, for the Treatment of Patients With NTRK-Positive Locally Advanced or Metastatic Solid Tumors

06/12/2024

FDA Approved Lilly Oncology's Retevmo (selpercatinib) for Adult and Pediatric Patients 2 Years of Age And Older With Advanced or Metastatic RET Fusion-Positive Thyroid Cancer

06/07/2024

FDA Approved Geron's RYTELO™ (imetelstat), a First-in-Class Telomerase Inhibitor, for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia

05/30/2024

FDA Grants Accelerated Approval for Lilly Oncology's Retevmo (Selpercatinib) for Pediatric Patients Two Years and Older With RET-Altered Metastatic Thyroid Cancer or Solid Tumors

Therapies

Report Broken Links

Have you encountered a problem with a URL (link) on this page not working or displaying an error message? Help us fix it! 
Report Broken Link