If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Genentech's parent company, Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars.
Genentech, a member of the Roche Group, has announced that it has been granted FDA priority review for its supplemental biologics license application (sBLA) for pertuzumab (Perjeta), together with trastuzumab (Herceptin) and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer (EBC). The FDA is expected to issue a regulatory decision by January 28, 2018.
The sBLA relies on data from the phase 3 APHINITY study. The international, randomized, double-blind, placebo-controlled, 2-arm study evaluated the efficacy and safety of trastuzumab and chemotherapy combined with either pertuzumab or placebo, as adjuvant treatment in 4805 patients who had operable HER2-positive EBC. The study’s primary endpoint was invasive disease-free survival (iDFS), which the study defined as the time that a patient lives without the return of invasive breast cancer at any site and without death from any cause after adjuvant treatment.
The rate of iDFS at 3 years was 94.1% in the pertuzumab, trastuzumab, and chemotherapy arm, and 93.2% in the trastuzumab, chemotherapy, and placebo arm. Estimated iDFS at 4 years, based upon data available to date, was 92.3% and 90.6% in the 2 arms, respectively.
The fact that the FDA has granted a priority review of the drug—a review designation available only to medicines that the agency has determined to have the potential to provide significant improvements in treatment, prevention, or diagnosis of a disease—suggests that the agency may see the APHINITY study’s results as more impressive than investors did. When results of the trial were announced in June, Roche’s stock sank by 5.2% on concerns that the high cost of pertuzumab therapy relative to the improvements that it offered would keep the drug from being widely used in low-risk patients.
An analysis published in the Journal of Clinical Oncology, which assessed cost effectiveness of pertuzumab plus trastuzumab in the earlier CLEOPATRA study (a study that assessed pertuzumab and trastuzumab in metastatic breast cancer), concluded that use of the combination was unlikely to be cost effective, at least in treating metastatic breast cancer, in the United Sates.
If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars. Additionally, some analysts have said that the fact that pertuzumab would extend the duration of a patient’s treatment will contribute to higher sales overall sales for Roche.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.