Lilly cancer drug gets ‘yes’ from FDA’s Advisory Panel in Informal Poll
On Thursday, an advisory panel to the US Food and Drug Administration has supported the approval of Eli Lilly & Co's experimental lung cancer drug necitumumab. But along with the backing, it has suggested measures to be taken to reduce the drug's effects.
These are the results of an informal poll carried out by the FDA and should be noted that official vote has not taken place. As per the poll, majority of the members think that positives of the drug overshadow its negatives.
The company stated that in their clinical trial, the drug has shown overall improvement in survival rate. But along with this, the risks including serious blood clots and deadly electrolyte imbalances have also been noticed.
The trial included 1,093 patients who received the drug along with chemotherapy drugs, gemcitabine and cisplatin. These patients had survival rate of 11.5 months in comparison to 9.9 months for patients who received just chemotherapy drugs.
During the vote, most panel members said that the survival benefits were modest, but also added that they are meaningful and according to the benefits conferred by other FDA-approved drugs. "This is a marginal benefit. But it's a marginal benefit in exactly the same range as everything else that's been approved for this disease", said panel member James Liebmann.
The news led the company's shares to move up by 8 cents at $87.33 on Thursday afternoon on the New York Stock Exchange.