Novartis has nabbed the U.S. Food and Drug Administration’s breakthrough therapy designation for its experimental medicine capmatinib as it joins Pfizer in the race to treat a tough-to-treat mutated lung cancer type.
Novartis aims to file for U.S. approval for oral capmatinib later this year as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC), the Basel-based company said on Friday.
Pfizer drug Xalkori in 2018 also won the FDA’s fast-track development and review designation for this form of lung cancer for which there is not yet an approved targeted therapy.
Drugmakers like Novartis and Pfizer are increasing using biomarker-driven drugs to treat patients with rare tumours — only about 3%-4% of lung cancer patients have the MET exon14 skipping mutation — that have proven very difficult for oncologists to fight with their existing arsenal of medicines.
“We look forward to working with the FDA and global health authorities to bring capmatinib to patients who currently have no available targeted therapy options,” said John Tsai, Novartis’s chief drug developer.
The FDA’s breakthrough therapy tag is meant to speed the development and review of drugs aimed at life-threatening conditions that may boost the standard of care.
By John Miller
Source: Reuters
Novartis will acquire Mariana’s lead candidate MC-339, a radioligand therapy (RLT) designed to target small-cell lung cancer. Last year, Mariana had raised $175m in a Series B round from several funds and pharma giant Eli Lilly.
The company’s aspiration to expand the use of its obesity products to cardiovascular indications has been successful. In March, its blockbuster drug Wegovy was approved by the US Food and Drug Administration (FDA) for reducing the risk of cardiovascular diseases in obese or overweight adults.
Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space.
