FDA News

FDA grants fast track designation to 5F9 for lymphoma subtypes

The FDA granted fast track designations to 5F9 for the treatment of relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma.

5F9 (Forty Seven Inc.) is a monoclonal antibody directed against CD47. It is designed to block the signal cancer cells use to avoid being ingested by macrophages.

“The FDA’s decision to grant fast track designations to 5F9 for the treatment of DLBCL and follicular lymphoma reflects the urgent need for safe and effective therapies for people living with these cancers, and the potential of 5F9 to help patients for whom existing options are limited,” Mark McCamish, MD, PhD, president and CEO of Forty Seven Inc., said in a company-issued press release.

The FDA based the fast track designations on results from an open-label, multicenter phase 1b/phase 2 trial of 5F9 in combination with rituximab (Rituxan; Genentech, Biogen) for patients with relapsed or refractory non-Hodgkin lymphoma, including DLBCL and follicular lymphoma.

Initial efficacy and safety data from the phase 1b portion of the trial likely will be released later this year.

Several other trials of 5F9 are underway.

A phase 1 trial is designed to assess monotherapy for patients with ovarian cancer and other solid tumors; a phase 1/phase1b trial will assess the agent in combination with azacytidine for patients with refractory acute myeloid leukemia; and a phase 1b/phase 2 trial will assess 5F9 in combination with cetuximab (Erbitux, Eli Lilly) for patients with advanced relapsed or refractory solid tumors, including colorectal cancer.

The FDA granted fast track designations to 5F9 for the treatment of relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma.

5F9 (Forty Seven Inc.) is a monoclonal antibody directed against CD47. It is designed to block the signal cancer cells use to avoid being ingested by macrophages.

“The FDA’s decision to grant fast track designations to 5F9 for the treatment of DLBCL and follicular lymphoma reflects the urgent need for safe and effective therapies for people living with these cancers, and the potential of 5F9 to help patients for whom existing options are limited,” Mark McCamish, MD, PhD, president and CEO of Forty Seven Inc., said in a company-issued press release.

The FDA based the fast track designations on results from an open-label, multicenter phase 1b/phase 2 trial of 5F9 in combination with rituximab (Rituxan; Genentech, Biogen) for patients with relapsed or refractory non-Hodgkin lymphoma, including DLBCL and follicular lymphoma.

Initial efficacy and safety data from the phase 1b portion of the trial likely will be released later this year.

Several other trials of 5F9 are underway.

A phase 1 trial is designed to assess monotherapy for patients with ovarian cancer and other solid tumors; a phase 1/phase1b trial will assess the agent in combination with azacytidine for patients with refractory acute myeloid leukemia; and a phase 1b/phase 2 trial will assess 5F9 in combination with cetuximab (Erbitux, Eli Lilly) for patients with advanced relapsed or refractory solid tumors, including colorectal cancer.

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