Merck and Pfizer’s Bavencio approved for renal cell carcinoma

pharmaphorum | May 15, 2019

Merck and Pfizer’s Bavencio approved for renal cell carcinoma
Merck KGaA and Pfizer’s immunotherapy Bavencio (avelumab) has been approved by the FDA in combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The accelerated approval was based on positive results from the Phase III JAVELIN Renal 101 study, which showed the combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib. This is good news for a drug that has faced some challenges recently. In March, Merck and Pfizer discontinued an ovarian cancer trial for Bavencio. The decision was based on several emerging factors since the trial’s initiation, including interim results from the separate JAVELIN Ovarian 100 trial announced in December showing that Bavencio was unable to improve progression-free survival when used as a maintenance therapy. That failure came just a few weeks after Merck and Pfizer conceded defeat in another phase III study of Bavencio, the JAVELIN Ovarian 200 trial in platinum-resistant or platinum-refractory ovarian cancer.

Spotlight

In today’s global pharmaceutical distribution environment, the risks to undermine product safety are significant. Counterfeiting and product diversion are major problems and growing. In 2007 the World Health Organization estimated that drug counterfeiting accounted for 1% of sales in developed countries and rose to more than 10% in developing countries. Just a few short years later in 2011, estimates suggested counterfeit drugs can range between 1% to 70% of the total market in developing countries and that even in highly controlled.

Spotlight

In today’s global pharmaceutical distribution environment, the risks to undermine product safety are significant. Counterfeiting and product diversion are major problems and growing. In 2007 the World Health Organization estimated that drug counterfeiting accounted for 1% of sales in developed countries and rose to more than 10% in developing countries. Just a few short years later in 2011, estimates suggested counterfeit drugs can range between 1% to 70% of the total market in developing countries and that even in highly controlled.

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