publication date: Oct. 21, 2016

Drugs and Targets Lartruvo Gets Accelerated Approval for Sarcoma; Tecentriq Approved for a Type of NSCLC

LARTRUVO (olaratumab injection, 10 mg/mL) in combination with doxorubicin received an FDA accelerated approval for the treatment of adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.

Lartruvo, in combination with doxorubicin, is the first FDA-approved front-line therapy for STS in four decades.

Sponsored by Eli Lilly & Co., Lartruvo is a platelet-derived growth factor receptor-alpha blocking antibody. When stimulated, PDGF receptors cause tumor growth. Lartruvo works by blocking these receptors, which may help slow or stop tumor growth.

The approval is based on data from the phase II portion of the pivotal JGDG trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.    The confirmatory Phase 3 trial, ANNOUNCE, is fully enrolled.

“For these patients, Lartruvo, added to doxorubicin, provides a new treatment option,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence. “This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s … Continue reading 42-39 Lartruvo Gets Accelerated Approval for Sarcoma; Tecentriq Approved for a Type of NSCLC

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