US FDA grants accelerated approval to Jazz Pharma’s Zepzelca to treat metastatic small cell lung cancer

Jazz Pharmaceuticals plc, a global biopharmaceutical company, announced along with its partner PharmaMar that the US Food and Drug Administration (US 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.

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.

The US 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. 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)).

"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 US market, expanding our presence in oncology."

Zepzelca will be commercially available in the US 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 US 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 MaríaFernández Sousa-Faro, PhD, president of PharmaMar. "The US FDA accelerated approval of Zepzelca underscores its potential to fill an unmet need in this often-overlooked SCLC community."

Zepzelca is administered by an intravenous (IV) infusion delivering a 3.2 mg/m2 dose over the course of one hour, repeated every 21 days until disease progression or unacceptable toxicity.Zepzelca can be administered in an outpatient clinic and its dosing schedule of a single infusion every 21 days may result in less time a patient receives treatment in the clinic or hospital compared to other options.

"In addition to the physical toll it takes on patients, a relapse of SCLC also takes a mental and emotional toll on the entire family," said Andrea Stern Ferris, president and CEO, LUNGevity. "The availability of Zepzelca presents new hope for patients and their loved ones, and we're eager to see its impact on the SCLC community."

The phase 2 trial of Zepzelca was an open-label, single-arm study, which enrolled a total of 105 SCLC patients at 26 hospitals in six European countries and the US. In the trial, platinum-sensitive and platinum-resistant patients were treated with Zepzelca 3.2 mg/m2, administered as a 60-minute IV infusion repeated every 21 days until disease progression or unacceptable toxicity.

The primary endpoint, ORR, was 35 percent and the median duration of response was 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an IRC).Zepzelca (lurbinectedin)also known as PM1183, is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.

Zepzelca for injection 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC) that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.



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