Roche’s Polatuzumab Vedotin as Combination Therapy & Entrectinib Receives FDA’s Priority Review for r/r Diffuse DLBCL & NTRK Fusion-Positive Solid Tumors

 Roche’s Polatuzumab Vedotin as Combination Therapy & Entrectinib Receives FDA’s Priority Review for r/r Diffuse DLBCL & NTRK Fusion-Positive Solid Tumors

Roche’s Polatuzumab Vedotin as Combination Therapy & Entrectinib Receives FDA’s Priority Review for r/r Diffuse DLBCL & NTRK Fusion-Positive Solid Tumors

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

Click here, Click here to read full press release/ article| Ref: Roche | Image: Pharmafile

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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