(Adds details on Tabrecta's price, analyst comment)
By Manojna Maddipatla and Manas Mishra
May 6 (Reuters) - Novartis AG on Wednesday priced its treatment for a hard-to-treat form of lung cancer at the U.S. wholesale acquisition cost of $17,950 for a 28-day supply, following the drug's approval by regulators.
The drug, Tabrecta, has been approved by the U.S. Food and Drug Administration months ahead of schedule to treat patients with a MET exon14 skipping-mutated non-small cell lung cancer that has spread to other parts of the body. (bit.ly/2xKvaqc)
Tabrecta is approved for both untreated and previously treated patients, regardless of prior treatment type, and is expected to be available to patients in the coming days, the company said.
This is the first approved treatment to specifically target METex14 mutated metastatic non-small cell lung cancer (NSCLC), a type of lung cancer with a particularly poor prognosis.
Drugmakers like Novartis and Pfizer Inc are increasingly using biomarker-driven drugs to treat patients with rare tumors that have proven very difficult for oncologists to fight with their existing arsenal of medicines.
With the Tabrecta approval, Novartis beats Pfizer Inc in the race to develop a treatment for this specific form of lung cancer. Pfizer drug Xalkori in 2018 also received the FDA's fast-track development for METex14 metastatic NSCLC.
"We estimate Tabrecta sales conservatively surpassing $500 million by the mid-2020s," Piper Sandler analyst Tyler Van Buren said in a client note.
Novartis had previously called it a "blockbuster," he said.
About 4,000-5,000 patients are diagnosed with METex14 metastatic NSCLC each year in the United States, according to Novartis. In contrast, NSCLC accounts for about 228,000 new diagnoses in the country each year, the company said.
Tabrecta, which Novartis licensed from Incyte Corp in 2009, got a priority review from the FDA in February.
The FDA approval triggers $70 million in milestone payments to Incyte from Novartis, Incyte said. The company is also eligible to receive 12%-14% royalties on net sales of Tabrecta.
The FDA said on Wednesday it also approved Foundation Medicine Inc's FoundationOne CDx assay as a companion test for Tabrecta. (Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta and Shailesh Kuber)