Perjeta is now the first cancer drug approved to treat patients before surgery. Developed by Roche's Genentech unit, and already approved for women with advanced HER2-positive breast cancer, Perjeta can now reach a huge new group of patients at early stages of the disease.
You might call Perjeta a guinea pig. The new breast cancer drug from Roche's Genentech unit could soon become the first approved for cancer patients before they've had surgery. It would also be the first approved under new FDA guidelines for speeding cancer drugs to patients with early-stage disease.
Roche's study looked at Perjeta in combination with Roche's Herceptin and chemotherapy, compared with Herceptin and chemo alone. Patients on Perjeta and Herceptin saw statistically significant improvements in tumor size compared with those in the Herceptin-only arm, the FDA reveiewers noted.
The U.K.'s cost-effectiveness police have turned up their noses at Roche's new breast cancer drug Perjeta. The National Institute for Health and Care Excellence (NICE) says the drug's ability to extend patients' lives is unclear--and that it's far more costly than currently available treatments.
EvaluatePharma researchers totted up sales for the last 5 years' worth of analysts' blockbuster picks--and found plenty of bad bets.
Chalk up another big win for Hal Barron and his R&D team extraordinaire at Genentech. The FDA today approved a new indication for Roche's ($RHHBY) cancer drug Avastin.
Roche tightened its lock on the breast cancer treatment market, and its expectations for many more billions of dollars in annual revenue, when an EU panel gave thumbs up for approval of Perjeta.
Roche moved a step closer to adding another gem to its crown as the leading provider of therapies against a form of breast cancer. European officials backed approval of the Swiss drug giant's Perjeta (pertuzumab) for use as part of a combo attack on HER2-positive breast cancers.
Once again, Roche's ($RHHBY) quarterly results are a snapshot of Big Pharma hopes and travails. The Swiss drugmaker pulled off a 4% sales increase to 11.27 billion Swiss francs ($12.1 billion), with help from targeted cancer drugs and diagnostics. Oncology, of course, is one of the industry's most fertile fields, especially for drugs matched to patients with particular genetic quirks.
Investigators behind the big T-DM1 breast cancer program took the lid off the last big data box from its pivotal study this morning, revealing that the armed antibody delivered a 32% reduction in the risk of death among patients in the pivotal Phase III study when compared to the standard-of-care arm.