PharmaMar and Bionical Emas have announced the launch of an Expanded Access Program (EAP) for lurbinectedin to treat patients in the United States with relapsed Small Cell Lung Cancer (SCLC), who are unable to enter clinical trials and there are no appropriate alternative treatments.
SCLC is a very aggressive cancer that is usually diagnosed with advanced, often metastatic disease, thus limiting the role of traditional approaches and usually posing a worse prognosis when compared to other lung cancers. In the U.S., approximately 10-15% of lung cancers are small cell1. Approximately 30,000 new cases of SCLC are recorded in the U.S. every year. The treatment of relapsed SCLC has not changed substantially in more than two decades.
SCLC is one of PharmaMar's priority research areas. In December 2019, the Company announced the filing of lurbinectedin's New Drug Application (NDA) for the treatment of relapsed SCLC with the FDA under the "accelerated approval" program.
"SCLC is a devastating disease for patients and their families, having limited effective treatment options. We are excited to be able to provide access to lurbinectedin to eligible patients across the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.
"I am happy to see the launch of the lurbinectedin EAP in the U.S. today. Relapsed SCLC is a very aggressive disease with existing second line treatments showing only limited effectiveness. As oncology physicians, we are constantly looking for new treatment options for our patients. There is only one approved drug for the second line treatment which has modest benefit and significant side effects, and there are currently no other open EAPs. Providing access to this new option for patients requires time and investment from the Company and it is greatly appreciated by physicians in the clinic," said Dr. William Jeffrey Petty, Professor, Hematology and Oncology, Wake Forest Baptist Health, Winston-Salem, North Carolina.