Shots:

• The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR)
• CROWN is P-lll- parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC were randomized in ratio 1:1 to receive LORBRENA monotherapy (n=149) or XALKORI monotherapy (n=147). Result: The 1EPs is (PFS) based on the blinded independent central review (BICR) and 2EPs involve PFS based on OS- ORR- intracranial objective response- and safety
• Lorbrena is a tyrosine kinase inhibitor (TKI) especially developed to inhibit tumor mutations and to penetrate the blood-brain barrier

 ­ Ref: Pfizer | Image: Michigan Health Lab