FDA expands use of Bayer cancer pill

Lung cancer trial data revised

WASHINGTON, Feb 26, (Agencies): The Food and Drug Administration on Monday expanded approval of a Bayer cancer pill to treat tumors of the intestinal tract that don’t respond to other treatments.

The drug is called Stivarga and regulators approved it to treat gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other FDA-approved drugs.

The FDA previously approved Stivarga to treat colorectal cancer. It works by blocking several enzymes that promote cancer growth.

The FDA approved the drug for the new use based on a study of nearly 200 patients who were randomly assigned to take Stivarga or a placebo pill.

Patients taking the drug experienced a nearly four-month delay in the growth of their tumors compared to taking a placebo.

Serious side effects of Stivarga in clinical trials included liver damage, severe bleeding, blistering and peeling of skin, high blood pressure, heart attacks and perforations.

Other drugs approved to treat intestinal tumors include Gleevec, from Novartis, and Sutent, made by Pfizer Inc.

Bayer HealthCare is a subsidiary of Germany’s Bayer AG. Lung cancer: Peregrine Pharmaceuticals Inc reported revised results from a mid-stage lung cancer study of its experimental drug bavituximab that appeared to be not as good as the data it originally posted in early September.

The company’s shares, which were up in premarket trade on Tuesday, fell as much as 10 percent on open on the Nasdaq. They later recouped their losses to trade flat around midday.

“I think what may be contributing to the (share fall) is that the difference in overall survival is not statistically significant,” McNicoll, Lewis & Vlak analyst George Zavoico said in an email.

The study was, however, for dose confirmation purposes and was never intended to show a statistically significant difference in median overall survival, Zavoico said.

Revised data from the 121-patient study showed that patients survived for a median of 11.7 months when given bavituximab along with chemotherapy, compared with 7.3 months for a control arm that consisted of patients on chemotherapy alone or chemotherapy along with a low dose of the drug.

Tuesday’s reworked analysis comes about five months after Peregrine said that the data it initially reported from the same study contained major discrepancies.

Peregrine, which was testing 1mg/kg and 3mg/kg doses of bavituximab, said in January that the discrepancies were found to be isolated to the placebo and the 1mg/kg treatment arms.

The company said it considered the 1mg/kg treatment arm as part of the placebo, or control arm, in the revised analysis to try and remove any potential bias accruing to the treatment group receiving the 3mg/kg dose.

Peregrine said it was preparing to discuss further development of the drug with the US Food and Drug Administration in a meeting by midyear and aims to be in a position to begin a pivotal study on the drug near year-end.

“Partnering interest remains high and the updates from this trial should help advance these discussions,” Peregrine Chief Executive Steven King said in a statement.

Analyst Zavoico said he treats Tuesday’s news as an opportunity to buy Peregrine stock.

Peregrine’s stock jumped nearly 50 percent to $4.50 in early September, following its announcement that bavituximab along with chemotherapy doubled the survival time of lung cancer patients.

The shares have, however, since lost about 64 percent of their value to their Friday close.

Bavituximab is one of Tustin, California-based Peregrine’s most important and advanced products. It is also being tested to treat breast cancer, pancreatic cancer and hepatitis C. Insulin drug: US regulators are likely to approve Novo Nordisk’s long-acting insulin drug in three years after a surprise rejection earlier this month, analysts forecast in a poll.

The delay, however, is expected to be costly, with analysts trimming their earnings forecasts for 2017 by over six percent.

Investors had expected the US watchdog to approve Tresiba after a positive recommendation from an advisory panel in November.

A Reuters poll found 13 out of 15 analysts expected an eventual approval of the drug between 2014 and 2018, with the average believing it would happen in 2016. One analyst saw a 50 percent chance of eventual approval while another predicted the Danish drugmaker would not overturn the rejection.

Data from Thomson Reuters StarMine showed analysts have cut their expectations for Novo’s revenues and earnings for each of the next five years in the wake of the FDA decision.

Analysts on average have scaled back 2013 sales estimates by 0.9 percent since February 11, while cutting them for 2017 by 3.4 percent. They have also trimmed forecasts for 2017 earnings per share by 6.2 percent.

Nine of the analysts in the Reuters poll predicted that the FDA rejection would also have a negative impact on the sale of Tresiba in Europe, where the drug has already been approved.

Analysts said the setback for Novo’s drug, also known as degludec, is good news for rival makers of insulin medicines, such as France’s Sanofi, whose Lantus product is threatened by Novo’s newer ultra-long-lasting treatment.

Exane BNP Paribas analyst Vincent Meunier forecast FDA approval of Tresiba in 2017 but said he expected a major impact on European sales.

“Physicians are likely to prefer Sanofi’s Lantus which the cardiovascular profile has clearly been demonstrated as safe,” he said.