Breakthrough Therapy Designation for Metastatic Non-small Cell Lung Cancer

Jun 17, 2020 by Smiti Munwani



Non-small cell lung cancer (NSCLC) is common and difficult to treat. Now FDA has granted BTD (Breakthrough Therapy Designation) to AstraZeneca and Daiichi Sankyo for the drug trastuzumab deruxtecan or 'Enhertu' for treating this kind of cancer.

This means that the pharmaceutical companies can now fast-track the development of this drug since it has cleared initial regulatory hurdles. Enhertu is meant for non-small cell lung cancer tumors that have a HER2 mutation and for patients who have already received platinum-based therapy but whose cancer is still metastatic.

While 2-4% of patients have the HER2 mutation, their prognosis is extremely poor as only 6-10% of patients are alive five years after the initial diagnosis.

Clinical trials have shown the efficacy of this treatment. Welcoming this move, Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: "We are encouraged by the promising evidence of activity seen with Enhertu in patients with advanced lung cancer and a HER2 mutation. We look forward to working closely with the FDA on the potential for Enhertu to become the first HER2-directed therapy approved for non-small cell lung cancer."

Earlier the drug was given BTD for HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. In 2017 it received BTD for HER2-positive metastatic breast cancer and approval for its use for the same in 2019.

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