FDA's Oncologic Drugs Advisory Committee voted 17-0 to recommend approval for ABP 215, a biosimilar for bevacizumab (Avastin)- Amgen + Allergan

The FDA's Oncologic Drugs Advisory Committee voted 17-0 to recommend approval for ABP 215, a biosimilar for bevacizumab (Avastin) manufactured by Amgen and Allergan, to treat a range of solid tumors. The committee determined that ABP 215 is highly similar to bevacizumab and there is no clinically meaningful difference between the two drugs.

Amgen and Allergan filed a biologics license application (BLA) for 6 indications: 1.Metastatic colorectal cancer, with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment.2.Metastatic colorectal cancer, with fluoropyrimidine/irinotecan- or fluoropyrimidine/oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen.3. Non-squamous non-small cell lung cancer (NSCLC), with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic disease .4. Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy.5. Metastatic renal cell carcinoma with interferon alfa. 6.Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease.

Some committee members and at least 2 public speakers expressed concern about recommending approval for all 6 indications, based on data from patients with advanced/metastatic NSCLC. But, committee members determined that the pharmacokinetic (PK) data and method of action were consistent enough to warrant their support..