FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

Two key figures at the US Food and Drug Administration’s Center for Drug Evaluation and Research have said the FDA’s recently finalized guidance on neoadjuvant treatments will speed drug approval for high-risk patients.

Tatiana Prowell, breast cancer scientific lead, Division of Oncology Products and Office of Hematology Oncology Products, and Richard Pazdur, director of the Office of Hematology and Oncology Products (pictured), wrote on the FDA Voice blog that they welcomed the new research, presented at ESMO in September, that Swiss drug major Roche’s (ROG:SIX) Perjeta (pertuzumab) improved survival by an average of nearly 16 months when added to standard treatment. While in the past, the next step would have been to wait for years while large clinical trials were conducted to determine if the drug also worked for earlier stages of breast cancer, this is beginning to change.

They explained that although most women diagnosed with early breast cancer have surgery first to remove their tumor and then drug treatment to reduce risk of recurrence (as adjuvant therapy), it is also possible to give the same anti-cancer medicines before surgery (as neoadjuvant therapy) with equally beneficial results. Most breast cancers will shrink when drugs are given before surgery, and some will completely disappear by the time of surgery. This is called a pathological complete response, or pCR. Patients with a pCR at the time of surgery are at much lower risk of having their cancers metastasize in the future.