Jazz preps first solid tumor launch with Zepzelca's small cell lung cancer nod

Jazz Pharmaceuticals with partner PharmaMar get FDA greenlight for SCLC drug Zepzelca. (Jazz Pharmaceuticals)

Jazz Pharmaceuticals is prepping its first solid tumor cancer treatment for launch in early July, focusing on physician awareness and education. That's in part because Zepzelca is the first drug approved for previously treated small cell lung cancer in more than 20 years.

Jazz has already added about 30 new people to launch Zepzelca, including its sales force, who'll take the informational campaign straight to oncologists—particularly key opinion leaders in the field.

The Zepzelca launch is physician-focused to make sure doctors are aware that the drug exists, Jazz Chairman and CEO Bruce Cozadd said. About 30,000 people in the U.S. are diagnosed with small cell lung cancer every year, and about 17,000 of them go on to second-line treatment.

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RELATED: PharmaMar, Jazz get FDA priority review for lung cancer drug

“Small cell lung cancer patients have some good first-line options, especially with some of the more recently introduced immuno-oncology treatments that provide better benefits," Cozadd said. "But we know the large majority of patients will, unfortunately, progress."

Zepzelca's advantages over the standard of care, Hymcamtin, include a shorter treatment window. Zepzelca is administered intravenously for one hour once every three weeks, while the older therapy requires a five-day IV course of treatment every three weeks.

That dosing regimen could provide a distinct edge during the COVID-19 pandemic, as cancer patients have been anxious about exposing themselves to the novel coronavirus at healthcare centers. 

“Certainly, there is a renewed interest right now in minimizing treatment times and trying to keep people in outpatient settings as much as possible to reduce transmission risk. But from a patient perspective, the amount of time you spend at an in-care facility impacts quality of life for patients living with a life-threatening disease and who may have limited time left,” Cozadd said.

Zepzelca also showed high tolerability and a strong safety profile, with less than 2% stopping treatment because of side effects during clinical trials. 

Jazz and development partner PharmaMar earned the FDA nod for Zepzelca last week, just four months after it was accepted for priority review. Jazz acquired the U.S. rights for lurbinectedin from PharmaMar in December, just days after PharmaMar had applied for FDA approval on its own. The deal included a $200 million upfront payment plus up to $250 million in regulatory milestones tied to approval timelines.

RELATED: AstraZeneca's Imfinzi gets FDA green light to challenge Roche in small cell lung cancer

The FDA has approved first-line and third-line treatments for SCLC in recent years, but the options for second-line treatment had remained unchanged since 1996 when the FDA gave SmithKline Beecham a go-ahead to market Hycamtin. 

Zepzelca is Jazz’s first solid tumor cancer drug, adding to an oncology portfolio that includes hematology therapies Vyxeos and Erwinaze. Jazz plans to continue to work with PharmaMar on additional Zepzelca indications, including as a possible add-on therapy to first-line treatments and for other tumor types.

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