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Roche Korea gets expanded approval for breast cancer drug
  • By Marian Chu
  • Published 2018.04.18 13:13
  • Updated 2018.04.18 13:13
  • comments 0

Roche Korea said that its breast cancer therapy Perjeta got the Ministry of Food and Drug Safety’s expanded approval as an adjuvant and neoadjuvant therapy to treat HER2+ breast cancer patients.

“HER2-positive breast cancer has a higher risk of recurrence than general breast cancer, and despite current post-operative adjuvant therapies, more than one in four patients have experienced recurrence within a decade, signaling unmet medical needs,” said Roche Korea’s Kim Su-jeong from the medical division.

“Because Perjeta and Herceptin block the activity of HER2 receptors in a complementary way, the combination therapy, as a pre-operative and postoperative adjuvant therapy for HER2-positive breast cancer patients, can offer more improved benefits than Herceptin alone,” she added.

The U.S. Food and Drug Administration gave an expanded approval for the Perjeta-Herceptin combination therapy as a postoperative adjuvant therapy in December last year

Perjeta now can be used as a adjuvant therapy for HER2+ early stage breast cancer patients at high risk for reoccurrence who have completed surgery. The therapy can also be administered as an adjuvant drug for a year before or after surgery, Roche Korea said.

The expanded indication of Perjeta was based on a multinational, multicenter phase 3 clinical trial APHINITY. Its results were published last June in the New England Journal of medicine. The most commonly reported grade 3 adverse effects include diarrhea, anemia, and neutropenia.

Findings from a separate BERENICE study published in the Annals of Oncology also proved the therapy effective when administered as an adjuvant drug for one year following surgery. The study, which pitted Perjeta against Herceptin for one year before and after surgery, showed the Perjeta arm to display similar levels of cardiac-related adverse events and safety profile as in other studies.


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