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Approvals (and Otherwise) in Oncology

There have been several big up-or-down moves in oncology drug development the last few days. J&J got unexpectedly early approval for their antibody Darzalex (daratumumab). Originally developed by Genmab, this one is anti-CD38, which is of especial importance in leukemia and myeloma, and the FDA has approved it for multiple myeloma. There’s another similar antibody in the works (SAR650984) from Sanofi, and another myeloma antibody (elotuzumab) against a different target is near the end of development as well. The myeloma landscape is changing dramatically.

Meanwhile, AstraZeneca got a jolt of good news, which they’ve long needed more of, with the early approval of Tagrisso (AZD9291, osimertinib), a kinase inhibitor targeted towards a particular EGFR mutation in non-small cell lung cancer. But a similarly targeted drug from Clovis Biotechnology, rociletinib (which is one of the recent acrylamide-containing irreversibly covalent kinase inhibitors), ran into some big trouble. The FDA wants more data, for one thing, and the reason that they want more data is that Clovis submitted preliminary clinical data to them earlier that have not held up. That was clearly done because they were in a race with AstraZeneca (and with time in general), but you’re walking on – or sprinting across – a flaming tightrope when you try something like that, and the results are clear. Clovis’ stock fell about 75% on the news: its investors are unhappy with the delay, unhappy with the revised numbers, and unhappy that they didn’t hear anything about this on the company’s recent earnings call (while management, as it turned out, had already gotten the bad news).

4 comments on “Approvals (and Otherwise) in Oncology”

  1. Hap says:

    I wonder if anyone in Clovis’s management was selling anything off in the interim. That would be dumb and evil, but also not unprecedented.

  2. Kevin Parker says:

    Math to comment? Math!? Will someone please think of us biologists?

  3. eyesoars says:

    @hap: also a very good way to get a visit from government investigators. In another life I worked for a high-tech (computing) company, and one of our primary customer’s employees mentioned to several of our employees that their new management wanted to dump us. Half a dozen of our employees went and sold stock, which tanked a few days later when we were publicly dumped a few days later.

    Several people were “deposed” [the actual term of art, I gather, for testifying in a deposition], and those who had sold were fined for 3x the losses they [almost] avoided.

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