Jazz Pharmaceuticals, well known for its narcolepsy blockbuster Xyrem, is banking on new drugs to generate about half of its revenue by 2022, CEO Bruce Cozadd said earlier this year. Six months on, the Dublin-based company has added another cancer med to its list of offerings.
The FDA Thursday approved Jazz’s blood cancer therapy Rylaze as part of a chemotherapy regimen to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). The drug, formerly known as JZP-458, is an asparaginase—an enzyme that fights cancer cells by starving them of the nutrients they need to survive—derived from the bacteria erwinia.
Jazz says it expects to start selling the drug in mid-July.
Rylaze is specifically approved for adults and children one month and older who've developed hypersensitivity to E. coli-derived asparaginase. Up to 30% of ALL or LBL patients treated with the widely used E. coli-derived version suffer hypersensitivity reactions, and the diseases' many pediatric patients simply can't tolerate that type of asparaginase med, a Jazz spokesperson said over email.
ALL crops up in roughly 5,700 patients a year, about half of whom are children. It's the most common form of childhood cancer, the FDA said. And making the case for Jazz's new drug even stronger, the only other approved treatments for patients who are allergic to the E. coli asparaginase have "been in global shortage for years," the regulator said in an approval announcement.
The drug won fast track designation in October 2019 and scored orphan drug status in ALL and LBL in June. Jazz filed Rylaze with the FDA under its Real-Time Oncology Review program, and the regulator has approved the drug ahead of the completion of Jazz's pivotal trial.
The FDA gave Rylaze the green light based on data from an ongoing phase 2/3 study in 102 patients with hypersensitivity to E. coli-derived asparaginases. The study looked at whether patients on the med could hit and maintain a certain asparaginase level and found the recommended dose would provide the target activity level in 94% of patients.
While the company has long depended on Xyrem to fuel its growth, Jazz now sees roughly half of its 2022 sales coming from a clutch of new drugs, Cozadd told Fierce Pharma earlier this year. Those drugs are Jazz’s sleep med Sunosi, its small-cell lung cancer drug Zepzelca, its Xyrem follow-up Xywav and, now, Rylaze.
Meanwhile, the company recently agreed to pay $7.2 billion for cannabinoid specialist GW Pharmaceuticals, teeing up entry into the epilepsy market with GW's potential blockbuster-in-waiting Epidiolex.