FDA panel votes 5-4 against Avastin’s approval for breast cancer
WASHINGTON An advisory panel for the Food and Drug Administration told the agency that Genentech’s colon and lung cancer drug Avastin should not be approved to treat advanced breast cancer, according to the wallstreetjournal.com.
The FDA typically follows the recommendations of its expert panels, but yesterday’s vote was only passed by one vote, 5-4. The company wants to market Avastin as a first-line treatment for patients with recurrent or metastatic breast cancer, based on a study sponsored by the National Cancer Institute. The NCI study compared patients taking Avastin along with the chemotherapy drug Taxol, to people taking Taxol alone.
The trial showed an apparent benefit for Avastin. Patients taking the drug had a median increase of 5.5 months in how long they lived without the disease getting worse. Median “progression-free survival” was 11.3 months with Avastin, and 5.8 months without it.
But FDA officials questioned some aspects of the drug. The agency stressed that patients taking Avastin in the main NCI study overall didn’t live significantly longer. It also said Avastin didn’t show a clear benefit in a separate study in patients with metastatic breast cancer that had previously been treated.
Several panel members said the lack of a proven survival benefit left questions about whether the drug was truly helping patients. “Our approval would rest completely on buying into progression-free survival,” said Ralph D’Agostino, chairman of the mathematics and statistics department at Boston University. “I don’t think we have that ability at the moment, given the data that’s before us.”
Other members said they felt there was meaningful evidence that Avastin could help patients, and an overall survival advantage can be difficult to prove when people may get multiple other therapies as their cancers progress.
Wyeth and GSK may see competition in pediatric vaccines
LONDON There may be a clash of the titans underway.
Pharma giants Wyeth and GlaxoSmithKline are set to go head to head with their competing childhood vaccines, but Wyeth dismissed any worries about the newcomer to the vaccine playground.
Wyeth’s Prevnar will remain a key sales driver for the company but would not be hindered by Glaxo’s Synflorix, said Emilio Emini, the U.S. group’s head of vaccine research and development, on Tuesday.
Prevnar, a vaccine for infants and children to prevent certain invasive pneumococcal diseases, is active against seven types of streptococcus pneumonia, which together account for some 80 percent of illnesses, Reuters reported Tuesday.
Glaxo’s Synflorix, which a company spokeswoman said remained on track for submission to European regulators by the end of 2007, targets 10 types, and even prevents inflammation of the middle ear.
But Emini said Synflorix was incomparable to the new version of Prevnar.
“Essentially, it is a direct equivalent of the original Prevnar,” he said in an interview with Reuters on the sidelines of the FT Global Pharmaceutical and Biotechnology Conference. “If you look at the residual 20 percent of disease (not addressed by Prevnar) and ask how much is covered by the GSK 10-valent vaccine, it’s actually a small percentage. How much is covered by Prevnar-13? It’s over 60 percent,” Emini said.
Wyeth intends to submit a new version of Prevnar, active against 13 strains, to both European and U.S. regulators by the beginning of 2009.
The original version of the vaccine was introduced in 2000. Third-quarter sales of Prevnar were up 24 percent from a year earlier at $634 million.
Biomira to make move to U.S. under new name
EDMONTON, Canada Biomira shareholders have approved a plan to move the company to the U.S. and to change its name to Oncothyreon Incorporated. Oncothyreon will be the parent corporation of a successor company of Biomira and its subsidiaries, according to Canada.com.
The biotech company, which focuses on cancer treatment, currently has a few drugs in its pipeline including Stimuvax, which it is developing with Merck to treat non-small cell lung cancer. That drug is currently in a Phase III clinical trial. The next drug that is furthest along in development is a small molecule called PX-12, which is a drug used to treat pancreatic cancer and is currently in a Phase II trial.
“We are very pleased to have received the strong support of our shareholders for our relocation and the revision of our capital structure,” chief executive officer Robert Kirkland said. The shareholders will receive one-sixth of a share of common stock of Oncothyreon in exchange for each Biomira share. The new company will be based in Seattle.