GlaxoSmithKline may receive FDA approval for Tykerb this week: analysts

GlaxoSmithKline may receive FDA approval as early as Tuesday for its experimental drug Tykerb (lapatinib), in combination with Roche's Xeloda (capecitabine), as a treatment for advanced or metastatic HER2-positive breast cancer in patients who have received prior therapy, analysts indicated Monday.

"This is going to be a significant milestone for Glaxo,'' remarked Navid Malik, an analyst with Collins Stewart. Nonetheless, Malik and other analysts predict a delay of several years before the drug will reach blockbuster status. "Initially it's going to be a very small indication -- only patients that are failing [with Roche's breast cancer treatment] Herceptin," added Irina Stratan of WestLB Research. She noted, however, that GlaxoSmithKline has "plenty of other indications coming, to enlarge the label." Bank of America's Chris Schott forecast the drug could generate sales of $1 billion in 2011, and Gbola Amusa of Sanford C. Bernstein expects sales to peak at $1.5 billion in 2012.

In reference to the market competition that Tykerb, if approved, could present for Herceptin in the treatment of HER2-positive breast cancer, CIBC World Markets analyst Brett Holley said he doesn't think GlaxoSmithKline's drug will have "a monumental impact right away." Nonetheless, he indicated that Tykerb should "slowly...come into earlier-line treatment," while other analysts suggested that Tykerb and Herceptin, which is marketed by Genentech in the US, could one day be used in combination.

Tykerb received fast-track status in the US and was filed with the FDA in September. GlaxoSmithKline submitted its filing for Tykerb in the EU in October and a decision is expected there around mid-summer.

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