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Lilly closes on US approval of lung cancer drug necitumumab

Indication for NSCLC looking likely after informal panel poll

Eli Lilly HQ 

Prospects for US approval of Eli Lilly's lung cancer candidate necitumumab are looking up after FDA advisors met to discuss the company's application yesterday.

While no official vote was taken by the Oncologic Drugs Advisory Committee (ODAC) an informal poll found that the panellists were in favour of approval of necitumumab - in combination with gemcitabine and cisplatin - for patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC).

The experts were reviewing data from Lilly's SQUIRE and INSPIRE trials, which formed the basis of a rolling marketing application for necitumumab which was filed at the end of 2014. They concluded that the drug provided a "modest but significant" benefit in this form of cancer, sometimes referred to as squamous cell carcinoma (SCC).

About 25% to 30% of all lung cancers are SCCs, and these tend to be aggressive with less than 5% of patients with advanced disease surviving for five years or more. Necitumumab increased survival by 1.6 months compared to placebo in the trials.

If the FDA follows its panel's advice Lilly could get a green light for necitumumab within the next two to three months as a first-line therapy for squamous NSCLC, and according to Lilly is the first drug to show a survival benefit when added to chemotherapy alone in this setting. 

Richard Gaynor, Lilly's senior vice president, product development and medical affairs for its cancer division, said: "Few advances have been made over the past two decades in the first-line treatment of advanced squamous NSCLC, leaving a significant unmet medical need.

"We believe necitumumab with gemcitabine and cisplatin represents a meaningful advance in the search for a new first-line treatment option and look forward to working closely with the FDA as they continue their review."

The panel did have some reservations, however, noting an increased risk of death from blood clots in one trial, although on balance they were in favour of adding to the armamentarium of weapons for squamous NSCLC and one panellist described the drug as "a temporary step forward."

Analysts are predicting sales in the region of $500m a year for necitumumab, a monoclonal antibody that blocks the binding site of the human epidermal growth factor receptor 1 (EGFR), noting that the drug will complement Lilly's second-line NSCLC therapy Cyramza (ramucirumab).

Other drugs targeting EGFR are already on the market for NSCLC, including orally-active therapies such as Roche's Tarceva (erlotinib), AstraZeneca's Iressa (gefitinib) and Boehringer Ingelheim's Giotrif (afatinib). Boehringer has just reported phase III data that showed Giotrif was more effective than Tarceva in treating squamous NSCLC, and says it is preparing to file for approval of a specific label claim for SCC. 

Meanwhile, Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) has been approved in the US and recommended for approval in Europe as a second-line treatment for squamous NSCLC after patients have progressed on initial chemotherapy, boosting survival by more than three months.

The stellar efficacy shown in trials of this and other checkpoint inhibitors suggest they could quickly progress to first-line use and come to dominate therapy.

Article by
Phil Taylor

10th July 2015

From: Sales

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