New Drugs and Expanded Indications

Below are postings for new drugs and indications from our corporate sponsors you should be aware of.  Please refer to the links below for announcements and details. To view a full list of approvals, please visit www.fda.gov.

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

03/23/2023

FDA Approves Incyte's Zynyz™ (Retifanlimab-Dlwr) For The Treatment Of Metastatic Or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)

03/17/2023

FDA Approves Novartis' Tafinlar + Mekinist for Pediatric Patients with BRAF V600E Low-Grade Glioma, the Most Common Pediatric Brain Cancer

03/06/2023

FDA Approves Coherus' UDENYCA® Autoinjector, the Only Pegfilgrastim Therapy Delivered in a Convenient, Easy-to-Administer Prefilled Autoinjector

03/06/2023

FDA Broadens Indication for Lilly's Verzenio® (abemaciclib) in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer

02/10/2023

FDA Approves GSK's for Jemperli (dostarlimab-gxly) for the treatment of Patients with Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer

02/10/2023

FDA Approves Stemline's ORSERDU (elacestrant) for the Treatment of Postmenopausal Women or Adult Men with ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer With Disease Progression

02/03/2023

FDA Approves Gilead's Trodelvy® (sacituzumab govitecan-hziy) in Pre-treated HR+/HER2- Metastatic Breast Cancer

01/31/2023

FDA Approves Lilly's Jaypirca™ (pirtobrutinib), the 1st & Only Non-Covalent (Reversible) BTK Inhibitor, for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

01/27/2023

FDA Approves Merck's KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA NSCLC

01/20/2023

FDA Approves SeaGen's TUKYSA® (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer

01/20/2023

FDA Approves BeiGene's BRUKINSA (zanubrutinib) for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

01/03/2023

FDA Approves Genentech's Lunsumio® (mosunetuzumab-axgb) for the Treatment of Adult Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

12/13/2022

FDA Approves Mirati's KRAZATI™ (adagrasib) as a Targeted Treatment Option for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation

12/13/2022

FDA Approves Genentech's Tecentriq® (atezolizumab) for the Treatment of Adult and Pediatric Patients Two Years of Age and Older with Unresectable or Metastatic Alveolar Soft Part Sarcoma (ASPS)

12/06/2022

FDA Approves Rigel's REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation

11/11/2022

FDA Approves AstraZeneca's Imfinzi and Imjudo with chemotherapy in the US for patients with metastatic non-small cell lung cancer

11/10/2022

FDA Approves New Indication for SeaGen's for ADCETRIS® (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma

11/09/2022

FDA Approves Regeneron's Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy as First-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)

10/26/2022

FDA Approves Janssen Biotech's TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

10/24/2022

FDA Approves AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC)

10/04/2022

FDA Approves Taiho Oncology's Lytgobi (futibatinib) for Adult Patients with Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

09/27/2022

FDA Approves Lilly's Retevmo® (selpercatinib) for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type

08/12/2022

FDA Approves Daiichi Sankyo & AstraZeneca's ENHERTU® (fam-trastuzumab deruxtecan-nxki) as the 1st HER2 Directed Therapy for Patients with Previously Treated HER2 Mutant Metastatic NSCLC

03/22/2022

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With MSI‑H/dMMR Advanced Endometrial Carcinoma, Who Have Disease Progression

Therapies

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