Shots: 

• The FDA’s PR designation to the combination of Polatuzumab Vedotin + bendamustine (B)+ Rituxan (rituximab- R) vs BR as monothx & Entrectinib are based on GO29365 & STARTRK (1-2- NG) and ALKA-372-001 study for r/r diffuse DLBCL- mROS1 NSCLC & NTRK fusion-positive solid tumors respectively
• GO29365 study results: mOS (12.4 vs 4.7 mos.)- mPFS (7.6 vs 2.0 mos.)- mDOR (10.3 vs 4.1 mos.)- CR (40% vs 18%); STARTRK (1-2- NG) and ALKA-372-001 study results: ORR (57.4% & 77.4%); mDOR (10.4 & 24.6 mos.); IC ORR (54.5% & 55%)
• Polatuzumab vedotin anti-CD79b ADC and has received FDA’s BT and EMA’s PRIME designation for r/r DLBC in 2017 with expected FDA’s approval on 19 Aug-2019. Entrectinib (RXDX-101) is a TRK inhibitor- inhibiting TRK A/B/C and ROS1 proteins with expected FDA approval on 18 Aug-2019

Ref: Roche | Image: Roche