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Tarceva: fast track approval opportunities

Posted on: 08/11/2003

Tarceva: fast track approval opportunities

The FDA has granted orphan drug status for Tarceva in patients with malignant glioma.

August 11, 2003 4:06 PM GMT (Datamonitor) - On August 8, Genentech [DNA] and OSI Pharmaceuticals [OSIP] announced that the FDA had granted Tarceva orphan drug status for malignant glioma, a very aggressive type of brain tumor. On the same day enrollment for a key phase II trial began. However, it is likely that Tarceva, Genentech's lead pipeline product, will struggle to live up to its hype.

Tarceva's phase II trial evaluating safety and efficacy in patients with malignant glioma, a highly aggressive and nearly always fatal form of brain cancer, has begun enrolment. The multi-center, open label trial will enroll around 110 patients who have relapsed following first line treatment.

The initiation of the phase II trial followed promising phase I trial results (22% response rate), although compared to the gold standard drug treatment for glioma, Schering-Plough's [SGP] Temodar (temozolomide), the results were not that impressive.

Nevertheless, very few drugs are active against glioma and the toxicity profile of Tarceva is improved over the available therapies. It is unlikely that Tarceva will challenge Temodar as treatment of choice for glioma, but the drug may gain approval for use in combination with Temodar or as a second line therapy.

The development of Tarceva in the glioma indication is more of a tactical product management move rather than an opportunity to gain substantial revenue from the drug. By targeting a niche cancer approval indication with high unmet need, OSI and Genentech are far more likely to gain approval than in a larger indication such as non-small cell lung cancer, where effective therapies are available and many innovative competitor products are also seeking approval.

Once approved in glioma, US physicians can prescribe Tarceva off-label based upon phase II or III trial results in other indications. Consequently, glioma may provide opportunities for OSI and Genentech, including a faster approval pathway, than the drug might expect in other tumor indications.

OSI and Genentech could still come unstuck though, as phase I results are typically more impressive than found in larger scale phase II trials, leaving the possibility that Tarceva may not gain the results required for approval in glioma.

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