The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215, Amgen’s proposed biosimilar to Genentech’s Avastin (bevacizumab), on July 13, 2017.  According to the announcement, the proposed indications and uses for ABP 215 include:

  1. first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy;
  2. use in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line ABP 215-containing regimen;
  3. the first-line treatment of unresectable, locally advanced, recurrent, or metastatic non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel;
  4. the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent;
  5. the treatment of metastatic renal cell carcinoma in combination with interferon alfa; and
  6. use in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

The FDA has established a public docket for comment on this meeting.  The docket number is FDA 2017-N-2732, and the comment period closes on July 10, 2017.

Amgen and Allergan announced that they submitted an application for ABP 215 to the FDA in November 2016, and according to Amgen, the BSUFA date (FDA’s target goal) for action on the application is September 14, 2017.  Amgen and Allergan also have an application for ABP 215 pending in Europe that was submitted in December 2016.