- Japanese pharma Takeda Pharmaceuticals on Friday secured approval for its drug targeting a specific group of lung cancer patients, putting the company in direct competition with several other heavyweight drug developers.
- The Food and Drug Administration gave Alunbrig (brigatinib) the go-ahead as a second-line treatment for non-small cell lung cancer (NSCLC) patients who have the anaplastic lymphoma kinase (ALK) mutation — about 5% of the NSCLC population.
- A 30-day supply of the drug will cost $14,250, or about $171,000 annually. While Takeda has said it wouldn't price the drug at the high end of the market, competing products all entered the market at lower wholesale costs.
Alunbrig brings Takeda into a market that is relatively small, yet stacked with big name players. The current standard of care for those with ALK-positive NSCLC is Pfizer's Xalkori (crizotinib). Patients who don't respond to or can't take Xalkori move on to either Roche's Alecensa (alectinib) or Novartis' Zykadia (ceritinib). Takeda's treatment adds a third option to the list.
But Takeda isn't settling just for second-line status. The company is targeting first-line as well with a Phase 3 trial putting Alunbrig head-to-head against Xalkori. The study aims to enroll 270 patients, and is expected to have primary completion in April 2019.
"Using these more potent, next-generation ALK-inhibitors appears to be showing some real impressive data, and so I think there's a real optimism that brigatinib will be very successful in this trial and [have] the potential to move it ahead into the front line," said David Kerstein, Senior Medical Director at Takeda Oncology in an interview.
Carving out market share in either category won't be easy, however. Roche, for example, recently unveiled topline results from its own late-stage trial that showed Alecensa outperformed Xalkori, data that could bolster a first-line nod.
The FDA's approval hinged on a mid-stage pivotal study, named ALTA, that enrolled 202 ALK-positive NSCLC patients and tested two different doses of the drug. An assessment of the trial by an independent committee review found an overall response rate of 48% for a 90mg once-daily dose and 53% for a 90mg to 180mg once-daily dose. Respectively, about 38% and 40% of patients in those two dosing groups demonstrated serious adverse effects that included pneumonia, respiratory failure, pulmonary embolism and bacterial meningitis.
In any case, this newest approval is likely to fuel Takeda's M&A drive, given the fast turnaround between taking control of Alunbrig and bringing it to market. The company, eager to expand its U.S. footprint, acquired Ariad Pharmaceuticals in January for $5.2 billion. The goal of the deal was both to expand Takeda's U.S. presence and, more importantly, get access to brigatinib.
As for pricing, the Takeda spokesperson said the company "purposely did not price Alunbrig at the high end of the market." When it received the FDA greenlight in late 2015, Alecensa was priced at $12,500 per month. As of 2014, Zykadia cost $13,200 per month while Xalkori cost $11,500. Those drug have likely undergone price increases over the last several years.