Shares of ImClone Systems rose 3.4% to $43.45 after US regulators approved an update to the labelling on cancer drug Erbitux.
The US Food and Drug Administration has approved an update to the Erbitux (cetuximab) label to include overall survival data as a single agent in epidermal growth factor inhibitor-expressing metastatic colorectal cancer (mCRC) patients after failure of both irinotecan- and oxaliplatin-based regimens. The new approval is based on prolonged overall survival from a large, randomised, multicentre, Phase III trial comparing Erbitux plus best supportive care to BSC alone in 572 EGFR-expressing mCRC patients after failure of the aforementioned regimens.
ImClone’s chief medical officer Eric Rowinsky said that the firm is pleased that “the FDA has recognised these data as the second disease setting where Erbitux has improved overall survival - which is the ultimate goal of all cancer therapies”. Martin Birkhofer, vice president of oncology global medical affairs at Bristol-Myers Squibb, ImClone’s US marketing partner, noted that Erbitux is now the only approved biologic therapy to demonstrate improved overall survival as a single agent in patients with metastatic colorectal cancer.
Goldman Sachs analyst May-Kin Ho issued a research note reaffirmed a ‘buy’ rating on ImClone’s stock with a $45 price target, saying that “we believe the label revision would enhance Erbitux's competitiveness against Amgen's Vectibix (panitumumab) in refractory CRC, although the increase in sales should be modest".