Series of FDA Approvals Delivers New Hope to Patients

OncLive Chairman,

Mike Hennessy

With a series of recent approvals, the FDA bolstered oncologists’ armamentarium for treating patients with melanoma, soft tissue sarcoma, and pancreatic cancer. These approvals are always tremendous victories for the researchers and pharmaceutical companies whose dedicated work and entrepreneurial spirit produced these novel products. But in the end, the real victors with these regulatory actions are the patients fighting these diseases and their loved ones.

Two of the recent FDA approvals were in melanoma. The first-in-class oncolytic immunotherapy talimogene laherparepvec (T-VEC; Imlygic) is now approved for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. The approval was based on the phase III OPTiM study, in which T-VEC significantly extended durable response rates compared with GM-CSF.

Also in melanoma, the FDA expanded the approval of ipilimumab (Yervoy) in melanoma to include adjuvant treatment of patients with stage III melanoma with pathologic involvement of regional lymph nodes >1 mm who have undergone complete resection including total lymphadenectomy. The approval is based on results from the phase III EORTC 18071 trial, in which adjuvant ipilimumab at a 10 mg/kg dose reduced the risk of recurrence by 25% versus placebo.

Patients with soft tissue sarcoma also received positive news from the FDA. Trabectedin (Yondelis) was approved for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have previously received chemotherapy that included an anthracycline. The approval was based on results from the phase III ET743-SAR-3007 trial, in which trabectedin reduced the risk of disease progression by 45% versus dacarbazine in patients with advanced soft tissue sarcoma.

Another agent, MM-398 (irinotecan liposome injection; Onivyde), was approved for use in combination with 5-fluorouracil (5-FU) and leucovorin as a treatment for patients with metastatic pancreatic cancer following prior administration of a gemcitabine-based regimen. The approval was based on data from the phase III NAPOLI-1 trial, in which the addition of MM-398 to 5-FU and leucovorin reduced the risk of death by 43%, with a median overall survival of 6.1 months for the MM-398 regimen compared with 4.2 months with 5-FU and leucovorin alone. There are several other oncology treatments currently under FDA review with action dates scheduled before the end of the year. Let’s hope that as the holiday season kicks into high gear, the FDA continues to deliver positive news to patients in need.