Roche Gets FDA OK for Injectable Version of Breast Cancer Drug

Xconomy San Diego — 

A new version of a combination drug marketed by Roche for early-stage and metastatic breast cancer with a specific genetic signature received FDA approval Monday for a formulation that can be delivered in minutes rather than an hour or more.

The antibody combo, delivered alongside IV chemotherapy, is intended for women with breast cancer that overexpresses a protein called HER2; each drug—both of which were developed by Roche subsidiary Genentech—is believed to attack tumors differently.

The newly approved drug, Phesgo, is a fixed-dose mix of pertuzumab (Perjeta) and trastuzumab (Herceptin) that uses technology developed by San Diego’s Halozyme Therapeutics (NASDAQ: HALO) to facilitate subcutaneous delivery instead of intravenous infusion. Approval comes nearly four months prior to the date the FDA had set for its decision.

The companies say Phesgo allows patients to receive the treatment in five to eight minutes—compared to typical administration via IV, through which the antibodies are delivered sequentially over about an hour to 2.5 hours. (The longer end of each time range is for the initial leading dose; the shorter, for subsequent maintenance doses.) The agency’s OK marks the first approval for a therapy that uses the Halozyme drug delivery technology, called Enhanze, to combine two antibodies in a single product.

The approval was made based on data announced in September from a study testing the drug combination, administered via injection, along with IV chemotherapy. The trial met its goal of showing similar levels of pertuzumab compared to patients who received the drug combo via IV plus chemotherapy.

In an earlier trial, 85 percent of patients preferred the treatment compared to standard IV administration due to less time spent in the clinic and more comfortable treatment administration. The newly approved drug can be administered by a healthcare professional in a treatment center or in a patient’s home as well as in a hospital setting.

For Halozyme, the approval represents the second that its technology has ushered to the market in 2020. In May the FDA green-lit a subcutaneous version of Janssen Biotech’s daratumumab (Darzalex) for multiple myeloma patients. Before this year three products developed using Enhanze had reached commercialization: a treatment from Baxalta, now a part of Takeda Pharmaceutical (NYSE: TAK), for adults with adult patients with primary immunodeficiency diseases, and two Roche oncology medicines.

In May the company projected its pharma partners would this year kick off three Phase 3 trials and one Phase 2 trial of formulations developing using Enhanze.

Halozyme late last year ended efforts to become a drug maker in its own right after an investigational pancreatic cancer treatment it was advancing failed a late-stage study.