Eli Lilly's Portrazza Gets FDA Nod, Carries Boxed Warning

Zacks Equity Research
Updated

Eli Lilly and Company LLY announced that the FDA has approved Portrazza (necitumumab) in combination with Gemzar (gemcitabine) and cisplatin for the first-line treatment of patients suffering from metastatic squamous non-small cell lung cancer (NSCLC).

This makes Portrazza the first biologic to be approved for the first-line treatment of metastatic squamous NSCLC. However, Portrazza’s approval in the U.S. comes with a boxed warning regarding cardiopulmonary arrest and hypomagnesemia.

We are encouraged by the FDA approval of Portrazza. Per information provided by Eli Lilly in its press release, NSCLC is the most common type of lung cancer. While NSCLC accounts for about 85% of all lung cancer cases, squamous NSCLC accounts for about 30% of all lung cancer cases. It has been observed that the five-year survival rate for patients with metastatic disease is less than 5%.

We note that Portrazza enjoys Orphan Drug status in the U.S.

The FDA approval of Portrazza comes as a major boost for Eli Lilly. The company needs to bring new products to market so as to make up for the loss of revenues from the genericization of drugs like Cymbalta and Evista among others.

Eli Lilly is a Zacks Rank #2 (Buy) stock. Some favorably ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Anika Therapeutics Inc. ANIK and Baxalta Incorporated BXLT. All three stocks carry a Zacks Rank #1 (Strong Buy).

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