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News From Charter Oak Corporate Sponsors:

Taiho 07/09/2025   Taiho Oncology and Taiho Pharmaceutical Announce U.S. FDA Acceptance of Supplemental New Drug Application for INQOVI® in Combination with Venetoclax to Treat Patients with Acute Myeloid Leukemia

Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content  06/30/2025

BMS U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels  06/26/2025 

BMS 06/26/2025  U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels

Astrazeneca 06/23/2025  Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

Merck 06/13/2025  FDA Approves KEYTRUDA® (pembrolizumab) for PD-L1+ Resectable Locally Advanced Head & Neck Squamous Cell Carcinoma as Neoadjuvant Treatment, Continued as Adjuvant Treatment Combined With Radiotherapy With or Without Cisplatin Then as a Single Agent

BMS Nuvation Bio FDA approves taletrectinib for ROS1-positive non-small cell lung cancer 06/11/2025

Merck 05/31/2025  KEYTRUDA® (pembrolizumab) Plus Trodelvy® (sacituzumab govitecan-hziy) Reduced Risk of Disease Progression or Death by 35% Versus KEYTRUDA Plus Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer (TNBC)

Astellas  Astellas Pharma US, Inc. is pleased to announce the U.S. Food and Drug Administration (FDA) approval of a 300 mg vial size (NDC: 0469-4425-30) for VYLOY (zolbetuximab-clzb) in addition to its current 100 mg vial size (NDC: 0469-3425-10). For more information, please visit VyloyHCP.com.  05/19/2025

Please click here for the full Prescribing Information.

For important state pricing disclosure information, click here

Important News and Information 

Merck 04/27/2025  KEYTRUDA® (pembrolizumab) as Perioperative Treatment With Standard of Care (SOC) Adjuvant Therapy Significantly Improved Event-Free Survival Compared to SOC Alone in Patients With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

BMS 04/11/2025  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

BMS 04/08/20025  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a Treatment for Patients with Previously Untreated Microsatellite Instability-High or Mismatch Repair Deficient Unresectable or Metastatic Colorectal Cancer

Astrazeneca 03/31/2025  Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer 

Exelixis 03/26/2025 Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors

Exeixis 02/15/2025 Exelixis Announces Final Five-Year Follow-up Results from CheckMate -9ER Trial Evaluating CABOMETYX® (cabozantinib) in Combination with Opdivo® (nivolumab) in Patients with Advanced Kidney Cancer at ASCO GU 2025

Pfizer  U.S. FDA Approves Pfizer’s ADCETRIS® Combination Regimen for the treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma 02/12/2025 For more detailed information, please see the Full ADCETRIS Prescribing Information, including Boxed Warning.

Astrazeneca 01/27/2025  Enhertu approved in the US as first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies

Astrazeneca 01/17/2025  Datroway (datopotamab deruxtecan) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

Astrazeneca 01/17/2025  Calquence plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma

01/07/2025  Pfizer Oncology is proud to announce the FDA approval of BRAFTOVI® (encorafenib) in a new indication as part of a combination regimen. The following information is available for State Society review:

• BRAFTOVI Full Prescribing Information including Medication Guide

Pfizer FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation 12/20/2024     BRAFTOVI Full Prescribing Information including Medication Guide

Astellas FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma  10/18/2024

BMS   U.S. FDA Approves 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) 3/14/2024

Genentech FDA Approves Genentech’s Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Cancer  10/15/2021

BMS Celgene  COVID-19 Our Response and Path Forward - 05/13/2020

Exelixis announces first 100 patients enrolled in Phase 3 02/25/2020

Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain 06/29/2020

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation 06/24/2020

06/17/2020

FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma

05/02/2020

05/22/2020

Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations  04/27/2020

09/30/2019 AstraZeneca - Tagrisso is the only 1st-line treatment for EGFR-mutated non-small cell lung cancer to deliver a median overall survival of more than three years Press Release

08/16/2-19 Celgene -

U.S. FDA Approves INREBIC® (Fedratinib) as First New Treatment in Nearly a Decade for Patients With Myelofibrosis  Press Release

09/29/2019 Merck - Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Increase in Pathological Complete Response Versus Chemotherapy as Neoadjuvant Therapy in Early-Stage Triple-Negative Breast Cancer (TNBC)  Press Release

10/01/2018 Takeda - Positive Results Press Release 

09/25/2018 AstraZeneca - Overall Survival Press Release 

09/24/2018 Astellas - Postive CHMP Opinion Press Release

08/06/2018 Teva - Updated Indication Press Release

06/28/2018 Array BioPharma - New Indication - BRAFTOVI™ (encorafenib) Press Release 

03/26/2018 Seattle Genetics - FDA Breakthrough Therapy Designation Press Release

N02-11-2016  Merck - New Indication  PressRelease.pdf

12-15-2015 - Genentech - ALECENSA^® (alectinib)  ALECENSAPracticeManagerDay1Letters_ATP.pdf