Eli Lilly’s ($LLY) been working hard to grow its oncology sales--and its sales, period. And now it has a new product that’s ready to help contribute.
Wednesday, the FDA green-lighted Lilly's soft tissue sarcoma therapy (STS) Lartruvo as an add-on to the chemo med doxorubicin. Thanks to the FDA's priority review tag, it was a speedy approval, based on data from a small mid-stage study, and applies to patients who can't be treated with radiation and surgery.
The Indianapolis drugmaker has been tearing it up in diabetes, partly because of Jardiance, the SGLT2 med it shares with Boehringer Ingelheim. But it needs more than that to power a revenue turnaround, needed after years of unproductive R&D and some serious patent-cliff woes--and it’s looking to oncology for the juice. There, Lartruvo will join lung cancer med Portrazza and lung and gastric cancer-fighter Cyramza in Lilly’s “new cancer launches” column.
Though STS hasn’t seen a new front-line treatment in years that could improve overall survival, Lartruvo’s market won’t be a big one--at least for now. While in the clinic, the med earned the FDA’s orphan drug tag, a distinction reserved for candidates that treat rare diseases. 2015 saw 12,000 new cases of STS, and close to 5,000 deaths from the disease, Lilly said, citing stats from the American Cancer Society--but not all those patients will be a match for Lartruvo, because STS has multiple subtypes.
Still, for those Lartruvo can treat, the med represents “an important step forward,” William Tap, the principal investigator for the drug’s registrational trial, said in a statement. As Lilly pointed out, the Lartruvo-chemo combo is the first front-line therapy for the disease in four decades to show it could improve overall survival.
Meanwhile, Lartruvo isn’t the only STS newcomer on the block. Last fall, U.S. regulators green-lighted Johnson & Johnson’s ($JNJ) Yondelis, a drug approved to treat advanced STS liposarcoma and leiomyosarcoma in patients who previously received anthracycline-containing chemo.
- read Lilly's release
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