Breast Cancer | Clinical

FDA Issues CRL for Oral Paclitaxel and Encequidar for Metastatic Breast Cancer

March 01, 2021

The FDA has issued a complete response letter to Athenex, Inc, regarding the New Drug Application for oral paclitaxel in combination with encequidar for the treatment of metastatic breast cancer. The FDA stated that the application review process has been completed, but the NDA is not ready for approval due to safety and efficacy concerns.

Can CDK4/6 Inhibitors Be Optimized for Breast Cancer?

February 25, 2021

Can treatment with inhibitors of cyclindependent kinases 4 and 6 be optimized for patients with breast cancer? This remains an open question 6 years after the first approval of a CDK4/6 inhibitor, palbociclib.

ODAC Votes to Wait on Neoadjuvant Pembrolizumab Approval in High-Risk TNBC

February 10, 2021

In a 10 to 0 vote, the FDA’s Oncology Drug Advisory Committee did not support the approval of pembrolizumab (Keytruda) in combination with chemotherapy as neoadjuvant therapy for high-risk, early-stage triple-negative breast cancer.

MBCC Offers Review of Burgeoning Advancements in Breast Cancer Management

January 24, 2021

The virtual 38th Annual Miami Breast Cancer Conference®, hosted by Physicians’ Education Resource®, LLC will feature presentations from industry thought leaders on innovations in the arena of breast cancer treatment, including topics about systemic therapy and beyond.