Category: Conditional Marketing Authorization

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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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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