FDA approves nivolumab and relatlimab-rmbw for melanoma

FDA Approves FoundationOne®CDx in Non-Small Cell Lung Cancer

FDA Approves Olaparib for High-Risk Early Breast Cancer

FDA Approves Nivolumab in Combination for Early-Stage NSCLC

FDA Approves FoundationOne®CDx to Identify MSI-H Solid Tumors

Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the FoundationOne^®CDx to be used as a companion diagnostic to identify patients with microsatellite instability high (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s Keytruda^® (pembrolizumab).

Read the Foundation Medicine announcement.

Posted 2/22/2022

FDA Approves FoundationOne®CDx as a Companion Diagnostic in Melanoma

On December 8, 2021, the U.S. Food and Drug Administration (FDA) approved FoundationOne^®CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations. 

Read the Foundation Medicine announcement.

Posted 12/8/2021

FDA Approves Pembrolizumab for IIB or IIC Melanoma Following Complete Resection

On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda^® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection. 

Read the FDA announcement.

Read Merck's announcement.

Posted 12/6/2021

FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

Read the FDA announcement.

Read Merck's announcement.

Posted 11/18/2021

Do Good Initiative: Share Your Insights!

As part of Breast Cancer Awareness month, Sanofi has launched a "Do Good" initiative where treatment insights will be gathered from healthcare providers through a brief survey. Once completed by a breast cancer treating professional, a $50 donation will be made by Sanofi to a patient advocacy group that supports underserved metastatic breast cancer patients. To greater the impact, Sanofi will match the donation made on behalf of the professional, which we believe will deliver more Good & further help underserved breast cancer patients.

Please take a moment to complete the survey and share your insights.

Complete Survey

Posted on 11/15/2021

FDA Grants Accelerated Approval to Asciminib for Chronic Myeloid Leukemia

On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved asciminib for adult patients with Ph+ CML in chronic phase with the T315I mutation.

Read the FDA announcement.

Read Novartis' announcement.

Posted 11/1/2021