Labeling for ImClone/Bristol-Myers Squibb's colorectal cancer medication Erbitux (cetuximab) has been updated to include overall survival data in the colorectal cancer setting. FDA approved the firms' sBLA for Erbitux as a monotherapy in epidermal growth factor inhibitor-expressing metastatic colorectal cancer patients after failure of both irinotecan- and oxaliplatin-based regimens, the sponsors announced Oct. 2.

Erbitux was previously approved for metastatic colorectal cancer in combination with the chemotherapy drug irinotecan ( Camptosar ) in patients whose tumor has progressed following treatment with Camptosar, or as a single agent in patients who are unable to tolerate chemotherapy treatment with Camptosar.

"This approval for Erbitux as a monotherapy offers an additional treatment option for an expanded patient population, specifically, patients who have failed both irinotecan- and oxaliplatin-based chemotherapy regimens," ImClone stated.

Erbitux is separately approved for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck with radiation or as a monotherapy in patients with recurrent or metastatic squamous cell cancer when platinum-based therapy has failed (¹ Also see "Erbitux Pricing Could Be Modified With Longer Treatment Cycles" - Pink Sheet, 2 March, 2006.).

The companies announced that FDA had granted the sBLA - including the first data of a targeted anti-cancer therapy to demonstrate overall survival as a single agent in the refractory colon cancer setting - a priority review in June (² Also see "Erbitux Gets Priority Review For Third-Line Colorectal Cancer Claim" - Pink Sheet, 11 June, 2007.).

The approval is based on prolonged overall survival data from a randomized, multicenter Phase III trial comparing Erbitux plus best supportive care to best supportive care alone in 572 EGFR-expressing mCRC patients after failure of irinotecan- and oxaliplatin-based regimens. BSC was considered to be all approved palliative therapies designed to alleviate pain and treat other effects caused by mCRC in this patient population.

Labeling for Erbitux previously stated that "the effectiveness of Erbitux for the treatment of EGFR-expressing metastatic colorectal carcinoma is based on objective response rates" and that "currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Erbitux for the treatment of EGFR-expressing, metastatic colorectal carcinoma."

Bristol and ImClone announced in July an amendment to the terms of their co-development and co-promotion agreement for Erbitux to fund the expansion of Phase II and Phase III clinical trials for breast, bladder, esophageal, gastric and stage 3 lung cancer (³ Also see "Bristol Boosts ImClone Funding To Accelerate Erbitux Development" - Pink Sheet, 31 July, 2007.).

-Jessica Merrill (j.merrill@elsevier.com)

Erbitux Approved As Monotherapy In Metastatic Colorectal Cancer Setting

More from Archive

More from Pink Sheet