BMS, Lilly's targeted drug Erbitux gets new FDA nod

Erbitux from Bristol-Myers Squibb ($BMY) and Eli Lilly ($LLY) has received a new first-line approval for targeted use against colorectal cancer. The agency OK comes along with approval for a companion diagnostic test to identify patients without the KRAS genetic mutation that can interfere with Erbitux's efficacy. It's the first good news in recent months for the drug, which has failed a couple of clinical trials for other uses.

The FDA approved Erbitux, an EGFR inhibitor, for first-line use against metastatic colorectal cancer with so-called "wild-type" KRAS. The FDA also approved Qiagen's KRAS diagnostic. The dual approval should expand use of the drug, which is also approved for head and neck cancer.

The approval relies on results from a European study conducted by Merck KGaA, which sells the drug outside the U.S. Qiagen says about 60% of patients with wild-type KRAS genes may benefit from anti-EGFR therapy and that the U.S. could save more than $600 million a year "by avoiding unnecessary use of medicines in colorectal cancer patients through determinations of their KRAS status," Pharma Times reports.

It was good news after Merck reported last week that the drug failed to hold off stomach-tumor growth any longer than standard chemotherapy. In May, Erbitux fell short in adjuvant treatment after colon-cancer surgery. Merck had hoped that positive data in the stomach cancer study would lead to a new indication for its second-best-selling drug. Analysts estimated that a gastric-cancer indication would be worth up to €300 million ($368.2 million) in additional sales. Last year, Erbitux brought in €855 million.

But today's approval was good for Lilly and Bristol-Myers Squibb as well as for patients with the condition. "Both response rates and overall survival in KRAS wild-type patients treated with the CRYSTAL regimen are important when considering the treatment options for patients with first-line mCRC," Dr. Eric Van Cutsem, professor of medicine and digestive oncology, says in the company's release.

The approval comes with boxed warnings. The companies point out that serious infusion reactions occurred in about 3% of patients in clinical trials, with fatal reactions occurring in fewer than 1 in 1,000 treatments.

- read the Pharma Times story
- here's the release