May 1, 2017
By Mark Terry, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration (FDA) granted Takeda Pharmaceutical Company ’s Alunbrig (brigatinib) Accelerated Approval for anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to crizotinib.
Takeda picked up the drug when it acquired Ariad Pharmaceuticals for $5.2 billion in January. Ariad also markets Iclusig for leukemia. Since its launch in 2012, the price for Iclusig rose 73 percent. U.S. Sen. Bernie Sanders specifically identified Ariad and Iclusig during the U.S. presidential election, noting that the price increase went from a monthly price of $9,580 in 2012 to $16,560 per month, or $198,720 per patient annually.
Alunbrig (brigatinib) is widely viewed as a likely blockbuster drug. A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA). The drug is also being evaluated in an ongoing Phase I/II and Phase II ALTA trial, as well as a Phase III ALTA 1L trial in comparison to crizotinb in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor.
“The rapid development of Alunbrig is a tribute to the dedication of many research scientists and clinicians who carefully designed and developed this new medicine to address unmet medical needs in the ALK+ NSCLC patient population,” said Andy Plump, Takeda’s chief medical and scientific officer, in a statement. “Most importantly, we would like to thank the patients and families who participated in the clinical trials.”
The FDA’s Accelerated Approval is typically given to drugs for diseases with few existing treatments and that have shown promise in clinical trials. Usually the approval is conditional on the results of an ongoing larger trial.
The approval was primarily based on the company’s pivotal Phase II ALTA (ALK in Lung Cancer Trial of AP26113) trial. It is an ongoing, two-arm, open-label, multicenter trial that enrolled 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib.
“In recent years, small molecule ALK inhibitors have revolutionized the treatment options for those with advanced ALK+ non-small cell lung cancer,” said D. Ross Camidge, director of thoracic oncology at the University of Colorado, in a statement. “Nevertheless, there is still a need for additional ALK inhibitors like brigatinib (Alunbrig), which have a manageable safety profile and may address mechanisms of clinical resistance to crizotinib, including progression in the central nervous system. The ALTA trial showed that brigatinib (Alunbrig) was highly effective post-crizotinib with the majority of patients who have received 180 mg once daily with a seven-day lead in 90 mg once daily achieving an overall response and a median duration of response greater than one year. Importantly, the extent of activity among those with brain metastases was also notable.”
The acquisition of Ariad was primarily to bolster Takeda’s oncology franchise. It’s best-selling blood cancer drug, Velcade, will face generic competition this year. Other key products will be losing patent protection beginning in 2020. Other oncology products include Adcentris (brentuximab vedotin) and Ninlaro (ixazomib).
After the acquisition, Takeda laid off 180 Ariad staff. Of the 300 Ariad employees, 120 found jobs in Takeda’s Boston operations. Of the other 180, the company reported that about 50 of them might find jobs at Takeda’s contract research organization, PRA. Takeda itself employs more than 2,000 people in Massachusetts.
