Zepzelca Is Approved Under Accelerated Approval Based on Overall Response Rate and Duration of Response Demonstrated in An Open-Label, Monotherapy Clinical Trial . Zepzelca Is Expected To Be Commercially Available in The U.S. In Early July . Investor Webcast On Wednesday, June 17 at 6:15 p.m. EDT .

DUBLIN, June 15, 2020 /PRNewswire/ --

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced along with its partner PharmaMar (MSE: PHM) that the U.S. Food and Drug Administration (FDA) approved Zepzelca™ (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.1 Zepzelca was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

The FDA approval of Zepzelca is based on monotherapy clinical data from an open-label, multi-center, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.2 The data, which appeared in The Lancet Oncology May 2020 issue, showed that in patients with relapsed SCLC, Zepzelca demonstrated an ORR of 35 percent and a median duration of response of 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC)).1

"Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients whose metastatic SCLC has progressed on or after platinum-based therapy," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Jazz congratulates PharmaMar on the successful development of Zepzelca and we are proud to partner with them to bring this new therapy to the U.S. market, expanding our presence in oncology."

Zepzelca will be commercially available in the U.S. in early July. As previously announced in December 2019, PharmaMar and Jazz entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to Zepzelca.

"Seeing first-hand the aggressive nature of SCLC and knowing that the large majority of those diagnosed will experience relapse, I am excited to see an effective new treatment demonstrating durable responses," said Dr. Jeff Petty, oncology specialist, Wake Forest Baptist Health. "For doctors, patients and their families, Zepzelca is an important and much-needed addition to the treatment landscape for relapsing SCLC."

"We are pleased to bring a new treatment choice to relapsed SCLC patients," said José María Fernández Sousa-Faro, PhD, president of PharmaMar. "The U.S. FDA accelerated approval of Zepzelca underscores its potential to fill an unmet need in this often-overlooked SCLC community." ...