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The company has filed an NDA for lurbinectedin and is seeking accelerated approval for treatment of relapsed small cell lung cancer.
PharmaMar, a Spain-based biopharmaceutical company focused on oncology, announced on Dec. 17, 2019 that it has submitted a new drug application (NDA) to FDA for lurbinectedin for the treatment of patients with relapsed small cell lung cancer (SCLC) under FDA’s accelerated approval regulations.
According to a company press release, 105 patients from Western Europe and the United States were invited to participate in a Phase II monotherapy basket trial for lurbinectedin, which met the primary endpoint of the overall response rate by both the investigator’s and the Independent Review Committee’s assessment. The company filed the NDA based on the positive Phase II trial results and the fact that relapsed SCLC treatment has not changed since FDA approved topotecan, a chemotherapy drug for the treatment of SCLC, in 1996
"The application for registration under accelerated approval regulations gives us the possibility that [FDA] could approve lurbinectedin in the US for treatment of small cell lung cancer in 2020 and that, if approval is obtained, could begin to be marketed in the second half of 2020 in the US," said Luis Mora, general manager of PharmaMar's Oncology Business Unit, in the press release.
“It is great to finally see some new therapeutic options arriving for small cell lung cancer patients, who represent a major unmet medical need,” added Dr. Charles Rudin, chief of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and principal investigator of the NCI Small Cell Lung Cancer Consortium, in the press release. “I have been following the emerging clinical trial data on lurbinectedin, which suggest appealing efficacy and a tolerable safety profile. I believe many treating physicians may welcome lurbinectedin, if approved, as a new standard of care option for their patients with recurrent small cell lung cancer.”