New treatment for metastatic HER2-positive breast cancer is called Margenza.
MarcoGenics says its new breast cancer treatment will be available in March.
Margenza, in combination with chemotherapy, is used treat patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
“Early detection and treatment have had a positive impact on the survival of patients with breast cancer, but the prognosis for people diagnosed with metastatic breast cancer remains poor, and additional treatments are needed,” said Hope S. Rugo, MD, professor of medicine and director of Breast Oncology and Clinical Trials Education at University of California-San Francisco Helen Diller Family Comprehensive Cancer Center, in a press release from MacroGenics.
“As the only HER2-targeted agent to have shown a PFS improvement versus trastuzumab in a head-to-head Phase 3 clinical trial, Margenza with chemotherapy represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” Rugo added.
FDA’s approval was based on safety and efficacy results from the pivotal Phase 3 SOPHIA trial.
The study, which included 536 patients, showed a statistically significant 24% reduction in the risk of disease progression or death with Margenza plus chemotherapy compared with trastuzumab (Herceptin, other brand names) plus chemotherapy.
The objective response rate for Margenza plus chemotherapy was 22%, and the ORR for trastuzumab plus chemotherapy was 16%. The final Overall Survival (OS) analysis is expected in the second half of 2021, according to MacroGenics.
Margenza includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity. In addition, the medication can cause infusion-related reactions (IRRs). IRRs occurred in 13% of patients treated with Margenza, with the majority reported as Grade 2 or less.
The recommended dosage of Margenza is 15 mg/kg, administered as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
Read more: FDA clears novel breast cancer drug