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Turning Point Therapeutics Receives Positive FDA Feedback on Repotrectinib NSCLC Application

NEW YORK – Turning Point Therapeutics said on Wednesday that the US Food and Drug Administration has provided feedback on the company's new drug application plans for repotrectinib, its TRK- and ROS1-targeted non-small cell lung cancer therapy.

In a pre-NDA meeting, the FDA agreed with Turning Point's plan to include at least six months of follow-up data from the Phase I/II TRIDENT-1 clinical trial in the application, which will include data from ROS1-positive advanced NSCLC patients who have and have not received prior treatment with other tyrosine kinase inhibitors.

News of the completed pre-NDA meeting with regulators comes after Turning Point announced data from the ongoing TRIDENT-1 study in April. At that time, 79 percent of ROS1-positive, TKI-naïve patients responded to repotrectinib; 42 percent of patients who had received one prior TKI and platinum-based chemotherapy responded to repotrectinib; and 28 percent of patients who received two prior TKIs responded to repotrectinib. Thirty-six percent of patients who received one prior TKI but no chemotherapy responded to the treatment and 59 percent of TKI pretreated patients whose tumors harbored a ROS1 G2032R solvent front mutation responded.

At the time, Turning Point shared its plans to meet with the FDA in a pre-NDA meeting and said it intended to present data on repotrectinib's intracranial activity during the second half of this year.

Early last month, Bristol Myers Squibb announced it would acquire Turning Point for $4.1 billion, gaining rights to repotrectinib. At that time, BMS said it expects that the drug would garner FDA approval as a first-line treatment for ROS1-positive advanced NSCLC patients during the second half of 2023 and become the new standard of care in this setting.

Turning Point is also evaluating repotrectinib combined with Novartis' Mekinist (trametinib) among patients with KRAS G12D-mutated solid tumors in the Phase I/II TRIDENT-2 trial.