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. 

04/19/2024

FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

04/08/2024

FDA Approved Daiichi Sankyo and AstraZeneca's ENHERTU® as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

03/19/2024

FDA Grants Approval of Supplemental New Drug Application (sNDA) for Takeda's ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

03/15/2024

FDA Approved Bristol Myers Squibb’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

03/08/2024

FDA Granted Accelerated Approval of BeiGene's BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma

03/08/2024

FDA Approves Bristol Myers Squibb's Opdivo (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

02/19/2024

FDA Approves AstraZeneca’s Tagrisso Plus Chemotherapy for the Treatment of Adult Patients With Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) NSCLC

02/19/2024

FDA Granted Traditional Approval to EMD Serono's Tepmetko (tepotinib) for Adult Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring MET Exon 14 Skipping Alterations

02/14/2024

FDA Approves Ipsen’s Onivyde® (Irinotecan Liposome Injection) Plus Oxaliplatin, Fluorouracil & Leucovorin (NALIRIFOX) for Metastatic Pancreatic Adenocarcinoma

01/22/2024

FDA Approves Janssen's BALVERSA® for Patients with Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

01/15/2024

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

01/03/2024

FDA Approves Novartis' Fabhalta® (iptacopan) as the First Oral Monotherapy for the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria

12/18/2023

FDA Approves Astellas' PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC)

12/15/2023

FDA Approves Merck’s WELIREG® (belzutifan) for Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI

12/04/2023

FDA Approves Lilly's Jaypirca® (pirtobrutinib) for Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy

11/28/2023

FDA Approves Springworks Therapeutics' OGSIVEO™ (nirogacestat) as the First and Only Treatment for Adults with Desmoid Tumors

11/17/2023

FDA Approves Astellas & Pfizer's XTANDI® (enzalutamide) patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis

11/17/2023

FDA Approves AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer

11/16/2023

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) + Chemo as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

11/16/2023

FDA Approves Bristol Myers Squibb's Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer

11/10/2023

FDA Approves Takeda Oncology's FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

11/01/2023

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

10/30/2023

The FDA approved Coherus' LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

10/24/2023

The FDA approved Servier's Tibsovo (ivosidenib) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation

10/20/2023

FDA granted accelerated approval to Genentech's Rozlytrek (entrectinib) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor

Therapies

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