Pfizer, Merck KGaA Lead Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Pfizer and Merck KGaA.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday, September 20, 2017 to Tuesday, September 26, 2017.
EC Approves Pfizer’s, Merck KGaA’s Potential Blockbuster Cancer Drug
The European Commission has approved Pfizer’s and Merck KGaA’s Bavencio (avelumab) as a monotherapy for treating adult patients with metastatic Merkel cell carcinoma (mMCC), a rare form of skin cancer. The drug is slated by some analysts as a potential blockbuster drug.
In November 2014, Merck KGaA and Pfizer announced their alliance, under which the companies agreed to collaborate on up to 20 high-priority immuno-oncology clinical development programs, including combination trials. In March 2017, the US Food and Drug Administration (FDA) approved Bavencio for treating mMCC in adults and pediatric patients 12 years and older as well as patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
The clinical development program for avelumab involves study of more than 15 tumor types, including breast cancer, gastric/gastroesophageal cancer, head and neck cancer, Merkel cell carcinoma (an aggressive form of skin cancer), mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma, and urothelial (e.g. bladder) cancer. Phase III clinical trials for ovarian cancer are ongoing with data expected in 2018 for 2019. Forecast 2021 sales are $1.2 billion, according to a Clarivate Analytics study.
Bavencio is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. Bavencio is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, Bavencio is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses, according to the companies.
Other PD-L1 antibody drugs include Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck & Co.’s Keytruda (pembrolizumab), which respectively had 2016 sales of $3.77 billion and $1.4 billion. Roche’s PD-L1 antibody, Tecentriq (atezolizumab), another immuno-oncology drug, was approved by the FDA in 2016 for treating bladder cancer.
Bavencio will have marketing authorization in the 28 countries of the European Union in addition to Norway, Liechtenstein, and Iceland. Bavencio is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.
Source: Pfizer and Merck KGaA