October is breast cancer awareness month, and as September ended, a new treatment received the FDA’s approval for advanced breast cancer and another was granted priority review for the adjuvant treatment of early breast cancer.
On September 28, the FDA approved
abemaciclib (Verzenio) for the treatment of adult patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer that has progressed on endocrine therapy. A CDK4/6 inhibitor, abemaciclib is currently approved in combination with fulvestrant in patients who have progressed on endocrine therapy. It is also approved to be given alone in combination with endocrine therapy and chemotherapy following metastasis.
Abemaciclib was evaluated in combination with fulvestrant in a randomized trial of 669 patients with HR-positive, HER2-negative breast cancer that had progressed following treatment with endocrine therapy and who had not received chemotherapy following metastasis. Median progression-free survival was 16.4 months in the abemaciclib plus chemotherapy arm, compared with 9.4 months in patients treated with a placebo and chemotherapy.
Abemaciclib as a stand-alone was evaluated in a single-arm study in 132 patients with HR-positive, HER2-negative breast cancer that had progressed on endocrine therapy and chemotherapy following metastasis. Nearly 20% of patients on abemaciclib presented with partial or complete shrinkage of their tumors for a median period of 8.6 months.
On September 29, Roche announced
that the FDA had accepted a supplemental Biologics License Application (sBLA) for pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and chemotherapy for adjuvant treatment of HER2-positive early breast cancer. While the FDA has already granted an accelerated approval for the combination, the current submission is aimed at converting it to a full approval.
The decision date for the sBLA is January 28, 2018.