The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine.
The drug would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the decision from the regulator was based on a late-stage trial which extended median progression-free survival (PFS) by nearly nine months.
AstraZeneca said on its experimental precision drug had slowed the progression of a common type of breast cancer in a late-stage trial, a boost for the company after its shares fell in July on results from a separate trial of the same drug for lung cancer.
Data released today by AstraZeneca from a late-stage trial combining its blockbuster cancer drug Tagrisso with chemotherapy to treat a type of lung cancer raises the bar for Johnson & Johnson’s rival treatment, analysts said.
J&J’s therapy was tested in patients in whom the disease progressed even after they were treated with AstraZeneca’s Tagrisso.
Novocure said today that its therapy failed in a late-stage trial to meet the main goal of improving survival rates in patients with a type of ovarian cancer.
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
The study showed that the therapy was able to help clear all signs of tumor in patients compared to neo-adjuvant placebo plus chemotherapy.
Concerned that the U.S. is becoming “overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations,” the House committee has launched its own investigation into the agency’s foreign drug inspection program.
The drug was being studied in patients with types of urothelial carcinoma who are eligible for cisplatin-based chemotherapy.