The Food and Drug Administration has approved Tecentriq in combination with Cotellic and Zelboraf for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.
The Food and Drug Administration (FDA) has approved the use of Tecentriq (atezolizumab) in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma, according to Genentech, the drug's manufacturer.
“When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening,” Dr. Levi Garraway, Genentech's chief medical officer and head of global product development, said in a press release. “Today’s FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma.”
The agency based its decision on data from the double-blind, placebo-controlled phase 3 IMspire150 trial, which evaluated the safety and efficacy of Tecentriq in combination with Cotellic and Zelboraf in individuals with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma.
The trial showed that adding Tecentriq to Cotellic and Zelboraf demonstrated a 4.5-month improvement of median progression-free survival, compared with placebo plus Cotellic and Zelboraf (15.1 months versus 10.6 months).
The most common side effects that occurred in patients who received the Tecentriq combination included, but were not limited to, rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%) and nausea (30%).
The release notes that the safety of the Tecentriq combination was consistent with known safety profiles of the individual drugs.
Check back later on what you need to know about this approval.