Roche Holdings Ltd.’s (RHHBY) subsidiary Genentech received some good news recently when the US Food and Drug Administration (FDA) cleared its breast cancer drug, Perjeta. The FDA approved Perjeta in combination with Roche’s existing breast cancer drug, Herceptin, and chemotherapy for treating patients suffering from HER2-positive metastatic breast cancer. The patients have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
The US regulatory body cleared the drug, on the assigned target date of June 8, 2012, on the basis of positive results from a randomized, double-blind phase III study (Cleopatra: n=808) which evaluated the safety and efficacy of the combination therapy versus placebo plus Herceptin and chemotherapy. Results revealed that patients treated with Perjeta plus Herceptin and chemotherapy lived 6.1 months longer (on a median basis) than those in the placebo arm without their tumor worsening.
We note that Roche’s biologics license application (BLA) for the drug was reviewed on a priority basis by the FDA, which implied a six month review period as opposed to the standard ten month period.
Roche is also seeking European approval of the combination therapy for either treatment-naïve breast cancer patients or breast cancer patients whose disease has returned following treatment in the early-stage setting.
Apart from Herceptin, other treatments in the market for the treatment of HER2-positive breast cancer include GlaxoSmithKline's (GSK) Tykerb. The strengthening of the breast cancer portfolio at Roche should boost the top line further since the market for breast cancer, the most common form of cancer affecting women globally, offers significant commercial potential. HER2-positive cancer, an aggressive form of breast cancer, affects 25% of the total breast cancer population.
Roche, headquartered in Basel, Switzerland, carries a Zacks #3 Rank (Hold rating) in the short-run.
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