The U.S. Food and Drug Administration accepted the companies’ New Drug Application for lurbinectedin under Priority Review.
Jazz Pharmaceuticals and Spain-based PharmaMar anticipate potential approval of a small cell lung cancer treatment by the end of summer. The U.S. Food and Drug Administration accepted the companies’ New Drug Application for lurbinectedin under Priority Review.
This morning the companies said the FDA gave a PDUFA target action date of Aug. 16 for the treatment of small cell lung cancer (SCLC) who have progressed after prior platinum-containing therapy. PharmaMar and Jazz submitted their NDA in December based on data from the Phase II monotherapy basket trial, which evaluated lurbinectedin for the treatment of relapsed SCLC. The trial met its primary endpoint of the objective response rate (ORR) and the results were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2019. The Phase II data showed that ORR was 35.2% in the total trial population and 45% in patients with sensitive disease, which was classified as those patients who suffered a relapse of the disease in a period greater than or equal to 90 days. The data also showed that ORR was 22.2% in patients with resistant disease, meaning patients who have suffered a relapse of the disease in a period of less than 90 days.
Following the Phase II data, PharmaMar announced in August 2019 that it would submit its NDA under accelerated approval of lurbinectedin as a monotherapy second-line treatment for SCLC. The accelerated approval program allows the submission of an NDA based on a Phase II study for serious conditions that satisfy an unmet medical need. SCLC is an aggressive form of the disease usually diagnosed in an advanced or metastatic state, which limits the role of traditional approaches. The treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved, PharmaMar said. SCLC represents between 10% and 15% of all lung cancers. There are approximately 30,000 new cases of SCLC diagnosed in the U.S. each year. Lurbinectedin was granted orphan drug designation for SCLC by FDA in August 2018.
Lurbinectedin (PM1183) is a selective inhibitor of the oncogenic transcription programs on which many tumors are dependent. Lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor, according to company data.
José María Fernández Sousa-Faro, president of PharmaMar, said in the United States, “lurbinectedin has the potential to become a therapeutic alternative for patients with relapsed small cell lung cancer, who have limited treatment options.”
In December, PharmaMar and Jazz entered into an exclusive license agreement for lurbinectedin in the United States. Ireland-based Jazz paid PharmaMar $200 million upfront, with the promise of nearly $800 million more in potential regulatory and commercial milestone payments.
As the company awaits the FDA’s decision of lurbinectedin as a monotherapy, last month it began to explore the drug in concert with immunotherapy drugs. The company launched a Phase I/II trial in combination with Roche’s Tecentriq (atezolizumab) as a potential treatment of patients with advanced SCLC.
