June 16, 2020 / 5:25 AM / a month ago

BRIEF-Pharma Mar: US FDA Approves Lurbinectedin To Treat Metastatic Small Cell Lung Cancer

June 16 (Reuters) - Pharma Mar SA:

* SAID ON MONDAY, ALONG WITH JAZZ PHARMACEUTICALS PLC, THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAD APPROVED ZEPZELCA (LURBINECTEDIN) FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION, AFTER PLATINUM-BASED CHEMOTHERAPY

* LURBINECTEDIN WAS APPROVED UNDER “ACCELERATED APPROVAL” BASED ON OVERALL RESPONSE RATE (ORR) AND DURATION OF RESPONSE (DOR)

* THE ANTI-TUMOR COMPOUND LURBINECTEDIN WILL BE MARKETED UNDER THE BRAND NAME ZEPZELCA

* PHARMAMAR WILL RECEIVE ROYALTIES, BASED ON LURBINECTEDIN’S NET SALES, RANGING FROM A PERCENTAGE IN THE HIGH TEENS, UP TO A MAXIMUM OF 30 PERCENT

* IN ADDITION, THE COMPANY WILL RECEIVE A PAYMENT OF $100 MILLION, AND COULD RECEIVE UP TO AN ADDITIONAL $150 MILLION WHEN FULL APPROVAL IS ACHIEVED

* LURBINECTEDIN IS EXPECTED TO BE MADE COMMERCIALLY AVAILABLE IN THE U.S. BY JAZZ PHARMACEUTICALS IN EARLY JULY

Source text: bit.ly/3e6NVE8

Further company coverage: (Gdansk Newsroom)

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