By ROBERT E. STEELE, Associated PressAssociated PressMEMPHIS, Tenn.
(AP) The Food and Drug Administration has approved a new drug for treating breast cancer that was developed by a company that made a blockbuster drug for the deadly disease that many Americans consider safer than chemotherapy.
Agency officials said Tuesday that the approval is needed to allow Pfizer to make the drug available to cancer patients in the U.S. without undergoing the expensive and complicated approval process that is often required in the world’s biggest economies.
The FDA approval of Pfizer’s “Brachycyte” is part of the agency’s plan to accelerate its approval of drugs that could be used to treat cancer.
The agency has approved nearly 300 new cancer drugs this year.
The drug is Pfizer/AbbVie’s first to use a gene therapy developed by Genentech Inc. to treat a type of aggressive breast cancer.
Genentech developed the gene therapy and a related gene therapy in 2014.
It has applied to become a Phase III clinical trial partner for Pfizer.
The U.K. biotech had hoped to have the drug approved in 2019, but the FDA rejected the application earlier this year because it could not prove it could treat patients with advanced cancers that are resistant to existing drugs.
Pfizer said in a statement that the drug will treat up to 40 percent of patients who have stage III or IV breast cancer, and that it is the first cancer drug that can be approved in the United States for this class of cancer without undergoing a drug approval process.
Pfalz said in the statement that it will now seek to complete Phase III of the trial, which is a stage when the company can show a promising safety profile for patients.
The company is also in talks with FDA regulators in the hopes of obtaining approval of the drug.
Pilgrim Biotech is the company behind a drug Pfizer is developing to treat breast cancer called Brachycytokine-Xa.
It was approved in February 2018 for use in people who have Stage IV breast cancers.
Pfrz said that the company plans to provide an interim report with results from its Phase III trial by April 2019.
The company has been using BrachychyrtokinesXa to treat the first stage of breast cancer since February 2018.
That stage has proven to be particularly difficult for most patients, who can have as much as 50 percent of their tumors shrink after treatment.
The first clinical trial for BrachycysXa has been completed, and it has shown promising results.
Pfizer said that it hopes to have it approved by April 2020.
The agency approved the drug to treat patients whose cancers were more advanced than stage III, and those who have advanced cancer with a mutation known as a non-small cell lung cancer.
The drugs can treat some cancers that were previously treated with drugs such as chemotherapy.
But many patients will need to be on the drug for several years, sometimes even decades.
Patients with the more advanced stages of breast and lung cancer are at increased risk of developing relapsed tumors that are hard to treat, and the drug could be especially helpful for patients who don’t have the cancer or the mutation to fight it.
Pfeil, a member of Pfiztralts medical advisory board, said Pfizer has been in discussions with the U:S.
Food and Drugs Administration for months about a possible extension to the drug’s approval.
She said Pfiztrals goal is to get the drug into the hands of patients as soon as possible and said the company is focused on getting the drug in the hands as many patients as possible.
Pfleil said that Pfizer had been working with the FDA for years to develop the drug, and said that she has not seen any evidence that the FDA has considered any concerns about safety.
She said that there is “no reason to be concerned” about safety or the drug being approved.
The federal agency also approved the next-generation drug in September that will target patients with aggressive tumors that were not treated with the first two Pfizer drugs.
It will be available in 2019.