Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Shots:

  • The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine
  • The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose
  • The CMA is valid in all 27 member states of the EU while the companies are ready to immediately ship initial doses to all the member state

Click here ­to­ read full press release/ article | Ref: BusinessWire  | Image: Market Place

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Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Shots:

  • The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients
  • Result: in NTRK fusion+ solid tumors, ORR (63.5%); mDoR (12.9mos.); In ROS1+ advanced NSCLC, shrank tumors in 73.4% of patients; DoR of 16.5mos. (14.6-28.6mos.); ORR (67.1%); in patients with CNS metastases with an intracranial ORR (62.5% & 77.8%); In pediatric patients, Rozlytrek shrank tumors in all children and adolescents who had NTRK gene fusions with two achieving a CR
  • Rozlytrek (entrectinib, qd) is a tumor-agnostic treatment for LA/m-solid tumors harboring NTRK1/2/3 or ROS1 gene fusions and has received EMA’s PRIME designation to treat NTRK fusion-positive, LA/m- solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies

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