Company news: Janssen, Pfizer, BMS and Boehringer Ingelheim

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The FDA gave Janssen the OK to market prostate cancer pill Zytiga for use in the pre-chemo setting. Until now the drug, used along with prednisone, has been approved for treating men with metastatic castration-resistant prostate cancer (mCRPC) who have already received chemo. Janssen had reported a survival benefit in the pre-chemo setting at June's ASCO meeting. "The approval now marks the first meaningful entry into the urology segment of the prostate cancer market since DNDN's Provenge,” wrote Credit Suisse analyst Lee Kalowski in an investor note. About 30% of Zytiga use has been in the pre-chemo setting, Kowalski observed, but urologist uptake has been small. He now expects “a more significant push” into that segment. Also expected to move into the chemo-naïve setting is Medivation/Astellas' Xtandi (enzalutamide), approved in September for mCRPC. Analyst firm GlobalData, in a statement today, predicted that Zytiga and Xtandi will dominate the mCRPC space, with peak Zytiga sales of $1.7 billion in 2018 and Xtandi sales increasing to $2.05 billion by 2022.

Makers of new oral blood-thinning drugs took advantage of a big gathering of hematologists to release data on their products. Pfizer and Bristol-Myers Squibb reported results of a Phase III study showing that treatment with Eliquis reduced risk from venous thromboembolism (VTE), and that patients benefited from an extra year of therapy. The factor Xa drug, awaiting FDA approval for non-valvular atrial fibrillation (NVAF), is approved in Europe for preventing VTE and for NVAF. The other drugmaker, Boehringer Ingelheim, said post-hoc analyses from five Phase III trials showed outcomes after a major bleed on Pradaxa (dabigatran) may be better than after a warfarin-associated bleed, despite the lack of a specific reversal agent. Pradaxa holds US approval for NVAF. The setting for both data downloads was the annual meeting of the American Society of Hematology (ASH) in Atlanta.
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