Double the Approvals! Double the Fun!

It looks like the Food and Drug Administration's oncology division was clearing out its pipeline of reviews and looking to catch a few soccer matches. You'll hear no complaints from sanofi-aventis (NYSE: SNY  ) or Novartis (NYSE: NVS  ) , which both received FDA approvals for their cancer drugs yesterday.

Sanofi's approval for Jevtana is especially impressive, because it comes less than three months after the company submitted its marketing application. The Prescription Drug User Fee Act (PDUFA) gives the FDA a goal of completing reviews within six months for priority reviews, which Jevtana had been granted, and the agency usually takes almost every day allowed.

Jevtana treats metastatic prostate cancer, but it won't compete against Dendreon's (Nasdaq: DNDN  ) recently approved Provenge. Jevtana is approved to treat patients after they've failed Sanofi's Taxotere; Provenge is a first-line therapy for use instead of Taxotere. Johnson & Johnson (NYSE: JNJ  ) and Medivation (Nasdaq: MDVN  ) both have prostate cancer drugs in late-stage testing, which could crowd the field considerably.

Novartis' approval of Tasigna isn't as big of a win, because the drug will just replace the company's own Gleevec as the standard of care for a special type of leukemia. Tasigna is currently approved as a second-line treatment, but it's getting bumped up to first-line status after beating Gleevec in a head-to-head trial.

Unfortunately for Novartis, another second-line treatment, Bristol-Myers Squibb's (NYSE: BMY  ) Sprycel, also beat Gleevec. Until we see results from a head-to-head trial between Sprycel and Tasigna, the direction of Novartis' combined sales of Gleevec and Tasigna will depend on how doctors interpret the data, which was fairly similar between the two studies.

The FDA may have approved two drugs in one day, but investors defiantly shouldn't interpret the oddity to assume that the FDA is lowering its standards. The same mantra still holds: Present good data, and the FDA will approve the drug.

It's tempting to get excited about Sanofi's early approval by the FDA, but Merck (NYSE: MRK  ) just announced a delay by the FDA earlier this week. Let's hold off on getting excited -- at least until we know who got out of the first round of the World Cup.

Novartis is a Motley Fool Global Gains selection. Investing internationally doesn't have to be scary, and it can certainly be profitable. Click here to grab a 30-day trial subscription to the newsletter, where you'll see all of our current picks for a global economy.

Fool contributor Brian Orelli, Ph.D., isn't getting as much work done this month. He doesn't own shares of any company mentioned in this article. Johnson & Johnson is an Income Investor selection and Motley Fool Options recommended buying calls on the stock. The Fool has a disclosure policy, which has a disclosure policy.


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  • Report this Comment On June 21, 2010, at 12:48 PM, LFriedhoff wrote:

    "Present good data, and the FDA will approve the drug."

    I am so glad you've said this. It's a truth that seems to get buried by excuses for poorly conducted development programs or poor drug products.

    In my experience, FDA has always been reasonable given the huge and complex responsibilities they have.

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