Pfizer’s Groton facility plays key role in recent FDA approvals

November 13, 2018 GMT

Groton — Pfizer Inc. is on a roll, gaining U.S. Food and Drug Administration approval of three anti-cancer drugs in the last two months.

Lorbrena, the most recently approved of the three, got the nod in early November, Pfizer has announced, following clinical trials that demonstrated its effectiveness in treating non-small cell lung cancer among patients with a specific gene mutation. In October, the FDA approved Talzenna for certain breast cancer patients, and in September it approved Vizimpro, a first-line treatment for patients with metastatic non-small cell lung cancer.

As with virtually all Pfizer products, the drugs were developed, in part, at the New York-based pharmaceutical’s research and development laboratories on Eastern Point Road in Groton.

“Pfizer has enjoyed some great success of late,” Geraldine Taber, Pfizer’s senior director of pharmaceutical sciences, said Monday in a phone interview. “Three approvals in two months is unprecedented.”

She said Pfizer hopes to secure a fourth FDA approval by year’s end.

With the need and demand for new drug treatments increasing, Pfizer’s Groton facility, where a variety of scientific disciplines share space, has stepped up the pace of drug development, Taber said. 

While Taber’s pharmaceutical sciences “team” formulates the recipe for a drug — the ingredients that hold it together and allow it to dissolve at the right time — as well as the way the drug is taken — orally, by injection or inhaler — other teams in Groton monitor patient safety during clinical trials; design and synthesize the molecules that are the basis of new drugs; develop regulatory strategies; and engage in pharmacokinetics, the study of the movement of drugs in the body.

“It’s a very diverse group of people,” Taber said. “The uniqueness of having all these different skill sets together at one site is what helps with the speed (of drug development). … We’re constantly looking for good scientists.”

In the case of Lorbrena, the new cancer drug, Taber said scientists at Pfizer’s La Jolla, Calif., oncology research center got things started and that the Groton facility was charged in 2014 with coming up with a recipe for the drug. The drug had to be safe for patients and it had to be produced in sufficient quantities to supply clinical trials.

Typically, the process leading to FDA approval of a drug can take up to 10 years, a time frame Pfizer had trimmed considerably in developing Xalkori, an earlier lung cancer drug, which was approved in 2011 — a mere four years after its discovery.

Lobrena, approved in a similar span, should be commercially available in two to three weeks at a cost of about $16,000 a month, according to a Pfizer spokeswoman. Both Xalkori and Lorbrena target tumors in lung cancer patients with a mutation in a gene known as anaplastic lymphoma kinase, or ALK. In some cases, the cancer spreads to the brain. Many patients with the disease initially respond to drugs like Xalkori, a tyrosine kinase inhibitor, but experience “tumor progression.”

“Over the years, Pfizer has transformed research, management and treatment for patients with ALK-positive non-small cell lung cancer,” Andy Schmeltz, global president of Pfizer Oncology, said in a statement. “Building upon our extensive understanding of tumor complexity and treatment resistance, Lorbrena was discovered by Pfizer scientists and developed specifically to inhibit tumor mutations that may drive resistance to other ALK tyrosine kinase inhibitors. We believe that Lorbrena will benefit patients with ALK-positive metastatic non-small cell lung cancer that have progressed on prior therapy and continue to deliver on our commitment to addressing unmet needs of cancer patients.”

Lung cancer is the leading cause of cancer death worldwide. The American Cancer Society estimates that 234,000 new cases of lung cancer will be diagnosed this year and that 154,000 people will die from the disease in 2018. Non-small cell lung cancer, or NSCLC, accounts for about 85 percent of lung cancer cases.

About 5 percent of the NSCLC tumors are ALK-positive.