Eli Lilly Gets FDA Panel Nod for Lung Cancer Drug, Despite Earlier Concerns

Published: Jul 10, 2015

Eli Lilly Gets FDA Panel Nod for Lung Cancer Drug, Despite Earlier Concerns
July 9, 2015
By Riley McDermid and Mark Terry, BioSpace.com Breaking News Staff

Eli Lilly has effectively received approval from an advisory panel of the U.S. Food and Drug Administration (FDA) for its lung cancer drug necitumumab, the agency said Thursday.

The news come on the heels of a published report Tuesday addressing concerns the FDA had about necitumumab. Though today’s panel did not vote, a majority of members polled said they supported approving the drug. The FDA is not required to accept these types of recommendations, but it usually does so.

Necitumumab is being considered for approval in combination with gemcitabine and cisplatin as a first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). The drug is a recombinant human IgG1 monoclonal antibody (mAb). It acts by binding to the human epidermal growth factor receptor (EGFR) and blocking interaction between EGFR and other molecules.

The FDA had originally expressed concerns that the drug might increase the risk of potentially deadly blood clots. Necitumumab increased patients’ overall survival odds, but it also increased their risk of blood clots.

A decision on approval is pending by the end of the year.

Patients in a clinical trial who received necitumumab lived a median of 11.5 months, which was 1.6 months longer than patients who received only chemotherapy. The FDA panel also pointed out earlier this week that patients with lung cancer typically have risk factors for blood clotting anyway.

“The target population of lung cancer has several inherent risk factors for arterial and venous thromboembolic events, including smoking, underlying advanced cancer, age and frequent co-morbid conditions such as hypertension and diabetes mellitus. Chemotherapy, in particular cisplatinum, is known to be associated with 2- to 6- fold increase in VTE risk, especially in the first 3-6 months of treatment.”

The study also suggested that histological differences in the tumor types, for example, adenocarcinoma versus squamous cell carcinoma, could account for the higher incidence of thromboembolic events (TEs). If the drug is approved, it has the potential to create $567 million in sales in 2020, according to analysts.

Lilly currently markets Cyramza, a drug for the treatment of non-small cell lung cancer for patients that attempted chemotherapy, but the cancer progressed. It is possible, if approved, necitumumab would be used as an initial therapy.

Other companies marketing treatments for NSCLC include Roche(RHHBY) (Avastin) and Bristol-Myers Squibb Company (BMY) (Opdivo).

Merck & Co. (MRK) has had good luck this year with cancer drugs, primarily Keytruda (pembrolizumab). In March 2015 the company ended its pivotal Phase III KEYNOTE-006 clinical trial early due to meeting its two primary endpoints. Keytruda was being studied for the treatment of advanced melanoma, and the drug showed statistically significant and “clinically meaningful improvement in overall survival and progression-free survival compared to ipilimumab.”

In research note published today, Piper Jaffray increased their price target on Lilly stock from $97 to $102, and gave it an “overweight” rating. Deutsche Bank (DB) analysts on June 28 reiterated a “hold” rating. Leerink Swann analysts raised their price target from $77 to $92 on June 26. Analysts with Cowen and Company set a price target of $90, up from $85 and reiterated a “buy” rating. Bank of America (BAC) analysts upgraded from a “neutral” to “buy” rating and increased the price target from $74 to $101 in a research note on Wednesday, June 24.


As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.

The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.

The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.

But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.

That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?

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