Roche gains blockbuster backing for breast cancer therapy in Europe

Roche ($RHHBY) moved a step closer to adding another gem to its crown as the leading provider of therapies against a form of breast cancer. European officials backed approval of the Swiss drug giant's Perjeta (pertuzumab) for use as part of a combo attack on HER2-positive breast cancers.

The European Commission is likely to take the advice of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and stamp an approval on Perjeta within months, following suit with U.S. regulators who green-lighted the antibody treatment back in June. Perjeta, which targets a specific site on HER2 proteins, has provided an average of 6.1 months of additional progression-free survival when used with Roche's Herceptin and chemotherapy compared with Herceptin and chemo alone.

As Reuters reports, the benefits of the combo of therapies don't come cheap: An 18-month course of treatment with Herceptin and Perjeta costs roughly $188,000. European payers have been relatively stingy on the reimbursement front, and Roche will of course need to gain their support to fuel its franchise in breast cancer.

Roche is also developing an armed version of Herceptin called T-DM1 that links its blockbuster therapy with an anticancer toxin that could extend the company's lead in market for treating HER2-positive breast cancers, which account for about a quarter of all cases of breast cancer. The muscled antibody, which is under FDA review, could expand the blockbuster franchise for Herceptin, which registered $4.8 billion in 2011 sales but faces potential biosimilars competition after its patents begin to expire in 2014 in Europe.

Perjeta was one of three new therapies to gain the CHMP's backing this week. An anti-binge-drinking drug called Selincro from Danish drugmaker Lundbeck notched a positive recommendation. Also, Alexza Pharmaceuticals ($ALXA) announced that the committee endorsed approval of its drug Adasuve for patients with schizophrenia.

- here's a link to the CHMP opinion on Perjeta
- see FiercePharma's article on Lundbeck's win
- check out Reuters' article on Perjeta
- and Alexza's release

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