Eli Lilly has won an accelerated FDA approval of its soft tissue sarcoma drug olaratumab with set of positive results from a small mid-stage study. Lilly plans to sell the drug as Lartruvo to a slice of patients for frontline use — the first such approval to come along in decades for this disease.
The drug targets PDGF receptors which cause tumor growth.
The agency’s green light comes just a month after the EU’s CHMP offered a positive opinion about a similar move in Europe, setting up a likely transAtlantic sweep for Lilly, which has been pouring resources into its oncology pipeline in recent years.
The FDA approved the drug, only its 18th OK so far this year, in combination with doxorubicin among patients who can’t be treated by radiation or surgery and in a group with a type of STS that can be treated with the chemo anthracycline.
“For these patients, Lartruvo, added to doxorubicin, provides a new treatment option,” said Richard Pazdur, MD, 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 approval more than 40 years ago.”
Lilly, which has begun to rack up a few new drug approvals after a long drought in the clinic, was able to present stats showing that the median survival rate for patients hit 26.5 months for the combo compared to 14.7 months for patients who received doxorubicin alone. Investigators also posted a median progression-free survival time of 8.2 months for the combo compared to 4.4 months for patients who received only doxorubicin. Tumor shrinkage registered at 18.2 percent against 7.5 percent.
This OK marks another important step forward for Lilly, which had been a perennial laggard in R&D. Later this year Lilly will follow up with its latest round of Phase III data for solanezumab, its big experimental therapy for Alzheimer’s. Most analysts expect mixed data at best as Lilly looks to break the lock on new Alzheimer’s meds after a decade-long run of failures.
Back in March Lilly won an approval for the psoriasis drug Taltz (ixekizumab) and still faces a decision on baricitinib for rheumatoid arthritis as well as the CDK 4/6 drug abemaciclib, now scheduled to wrap a Phase III next year as Lilly is forced to wait for the full data set.
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