FDA warns of death risk from AbbVie’s Venclexta; Pfizer, Merck scrap another Bavencio trial

By PharmaCompass

2019-03-28

Impressions: 86 Article

After halting enrollment of patients in multiple myeloma trials due to incidents of patient deaths, the United States Food and Drug Administration (FDA) issued a warning against the use of AbbVie and Roche’s Venclexta for multiple myeloma.

FDA informed it had reviewed data from the BELLINI clinical trial whose interim results showed an increased risk of death for patients receiving Venclexta as compared to the control group. Data from the trial showed Venclexta increased the relative risk of death by about twofold compared to a placebo.

In an interim survival analysis, 41 of 194 (21.1 percent) patients in the experimental arm had died, versus 11 of 97 patients (11.3 percent) in the placebo group.

Venclexta (venetoclax) is currently under clinical trials for several blood cancer indications including myelodysplastic syndrome and mantle cell lymphoma. It generated US$ 344 million for AbbVie in 2018 revenues.

FDA has asked healthcare professionals and patients to report any Venclexta side effects to its MedWatch Adverse Event Reporting program, even as it considers the drug to be a safe and an effective treatment for its approved indications, such as chronic lymphocytic leukemia and acute myeloid leukemia.

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Another drug that suffered a trial setback is Pfizer and Merck KGaA’s Bavencio (avelumab), a drug competing with blockbusters like Keytruda and Opdivo. In a joint statement, the companies announced they would be discontinuing a phase III trial that evaluates a combination therapy of Bavencio-chemotherapy followed by a Bavencio-Talzenna treatment.

The trial included patients with untreated advanced ovarian cancer in stage III or stage IV of the disease. This comes few months after the companies suffered a blow as Bavencio failed a first-line study, in patients with certain forms of ovarian cancer.

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