Roche lung cancer drug bags another 'breakthrough' at the FDA

Roche has won bragging rights to the FDA's new breakthrough therapy designation for its ALK inhibitor alectinib, a non-small cell lung cancer drug which will be featured at an upcoming presentation at the European Cancer Congress in Amsterdam at the end of this month.

This is Roche's ($RHHBY) second BTD (its first went to the Phase III chronic lymphocytic leukemia drug obinutuzumab), which puts the pharma giant in league with Novartis ($NVS) and Johnson & Johnson ($JNJ). Novartis holds a record of three BTDs while J&J is partnered on ibrutinib, which has three BTDs in its own right for various indications.

The pharma giant's subsidiary Chugai -- which is majority-owned by Roche -- is preparing to present new efficacy and safety data at ECC that persuaded the FDA to include it on the list of breakthrough drugs the agency promises to help accelerate through clinical development.

At ASCO last summer investigators unveiled promising mid-stage data on RO5424802/CH5424802 demonstrating a 93.5% overall response rate with 30% tumor shrinkage within weeks of therapy for most patients.

There's a considerable discussion underway among drug developers about just what the breakthrough drug designation is worth. The agency says it will open its doors to development teams looking to adapt clinical trials or speed up decisions on issues like manufacturing. In the cancer field the agency has been particularly open to major drug developers like Roche/Genentech and J&J. But it's still early days in the process, with no clear idea of how this will pan out in terms of timelines and approvals.

"At ECC this year we will present important updates for both investigational and approved medicines," said Hal Barron, Roche's head of global product development. "These data reflect our commitment to develop new targeted anti-cancer medicines as well as to explore how our approved medicines, such as Zelboraf, Avastin and Herceptin, can benefit more patients."

- read the press release