Jazz Pharmaceuticals (JAZZ) and partner PharmaMar have announced a surprise early approval from the US FDA for its Zepzelca treatment for adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This comes notably ahead of the 8/16 PDUFA date.
Zepzelca (lurbinectedin) 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 company said.
Data from an open-label, multi-center study 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.
“Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients,” said Bruce Cozadd, JAZZ CEO. “While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment.”
Zepzelca will be commercially available in the U.S. in early July. Under an exclusive license agreement, which became effective in January 2020, Jazz received all the U.S. commercialization rights to Zepzelca.
The treatment 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.
Shares in JAZZ closed 6% higher in Monday’s trading, although the stock remains at depressed levels. “The stock is down -26% year-to-date as we enter an event driven 2H2020 which we think leaves a favorable set-up” commented RBC Capital analyst Randall Stanicky on June 15.
Following the news, he reiterated his buy rating with a $147 price target (33% upside potential). From here, Stanicky is watching for the anticipated 2H20 read-out of the Phase 3 ATLANTIS combo trial (Lurbinectedin + doxorubicin versus Topotecan or CAV).
Indeed, analysts have a bullish Strong Buy consensus on the stock, with 8 recent buy ratings vs 2 hold ratings. Meanwhile the average analyst price target stands at $156 (41% upside potential). (See JAZZ stock analysis on TipRanks)