The reason: an advisory panel for the Food and Drug Administration will review the company's breast cancer drug, neratinib, at a half-day meeting Wednesday morning. Then they would take neratinib (tentative brand name: Nerlynx) to further lower their risk of breast cancer returning. In a big clinical trial, it neratinib reduced the rate of breast cancer recurrence within two years by a third. A study of Roche's breast cancer drug Perjeta will become available after the expert panel votes, but before the FDA is expected to make a decision on neratinib. The biggest issue raised by the FDA documents is whether the many changes that were made to the neratinib study affected the statistical validity of the result.

Source: Forbes May 22, 2017 18:11 UTC