Lilly's middling lung cancer drug wins FDA approval with a restrictive label

Eli Lilly ($LLY) won FDA approval for a lung cancer treatment that posted only a marginal survival benefit in late-stage clinical trials, gaining clearance to treat a small population of patients with particularly serious disease.

The antibody therapy, necitumumab, is approved to be dosed alongside two types of chemotherapy for patients with lung cancer that has spread elsewhere in the body. The treatment, to be marketed as Portrazza, is indicated only for patients with squamous non-small cell lung cancer--which accounts for about one-quarter of all lung cancer diagnoses--who haven't received any form of therapy.

Portrazza's limited label is the result of some so-so results in Phase III. A combination of Lilly's treatment and gemcitabine and cisplatin extended patients' lives by just 1.6 months compared with the old chemotherapies alone, and Portrazza's positive effect on progression-free survival amounted to less than a week. The treatment failed to demonstrate any significant benefit in a trial on the more common nonsquamous NSCLC.

Once on the market, Lilly's therapy will carry a black-box warning advising physicians of its ties to cardiac arrest and sudden death due to blood clots, safety concerns that forced the company to halt an earlier clinical trial on the antibody.

Despite the treatment's limited effect, a panel of FDA advisers largely supported Portrazza's approval at a panel meeting in July. Oncologists want options, panelists said, and for patients with particularly advanced disease, a shot at even a modest benefit is worth it.

The FDA's cancer division under Richard Pazdur has taken the same tack in recent years, handing down speedy approvals to scores of novel oncology agents and indicating them for the most severe malignancies. From there, the onus is on drugmakers to make a clinical case for wider indications.

- read the statement

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