EMA loosens limits on Avastin in breast cancer

When European drug regulators meet, their new decrees set off a slew of headlines. This week was no different. But among the recommendations and approvals and warnings, one stood out. The European Medicines Agency is relaxing recently imposed restrictions on Roche's Avastin.

The cancer drug has been under scrutiny as a breast cancer treatment on both sides of the Atlantic. In December, the European body said Avastin should be used to treat metastatic breast cancer only when paired with the chemo drug paclitaxel. Officials now say Avastin can be used in combination with another Roche drug, Xeloda.

This decision comes as Roche's Genentech unit is preparing to defend Avastin's breast cancer indication at an FDA hearing. U.S. regulators moved to pull that approval last year, but Genentech is appealing that decision. Although the drug can be used off-label for breast cancer, the lack of an FDA approval could interfere with insurance reimbursements.

The EMA's move also comes on the heels of Roche's Q1 financials, which suffered from a decline in Avastin sales. The European move could help turn that tide, but it's the U.S. sales that Roche really needs. Whether looser restrictions in Europe inspire leniency from the FDA remains to be seen.

- see the Reuters news

ALSO: The European Medicines Agency backed the safety of bisphosphonate drugs used to treat osteoporosis but asked for a new warning about the risk of rare fractures. Report

Suggested Articles

An oncologist leader RBC Capital Markets interviewed expressed comfort that Trodelvy will succeed in earlier-line TNBC and in HR-positive disease.

Gilead Sciences is the latest drugmaker to settle Justice Department claims that its charity contributions were actually kickbacks.

J&J figures its partner Genmab owes a share of Darzalex Faspro royalties to Halozyme for its subcutaneous delivery tech. Genmab doesn't agree.