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) […]Read More
Shots: The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was living with someone with an influenza infection confirmed by a rapid influenza diagnostic test Result: The proportion of household members who developed influenza (1.9% vs 13.6%); well tolerated with no […]Read More
Shots: The approval is based on an sNDA which includes data from CAPTAIN study assessing Trelegy (qd, 100/62.5/25, 200/62.5/25, 100/31.25/25, and 200/31.25/25 mcg) vs FF/VI (100/25 and 200/25 mcg) to patients whose asthma was inadequately controlled despite treatment with ICS/LABA Results: Trelegy (qd, easy-to-use inhaler) demonstrated improvements in lung function, presented at ERS Congress. The […]Read More
Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up to 4 or 6 cycles), followed by either sintilimab or […]Read More
Shots: The sNDA is based on three studies in 500+ patients with NDD-CKD. The first P-III study involve assessing Evrenzo vs darbepoetin alfa resulted in meeting 1EPs of non-inferiority and maintenance of Hb levels over time and is well tolerated The other two studies (one P-II & one P-III) supported the safety and efficacy in […]Read More
Shots: The sNDA follows clinical, non-clinical, chemistry, manufacturing and controls (CMC) data and P-II study results assessing Tislelizumab in 113 patients with LA or metastatic UC prior treated with PD-L1+ in China & South Korea The NMPA granted second PR designation to Tislelizumab following the two PR designation of Zanubrutinib for r/r MCL and r/r […]Read More
Shots: The sNDA application is based on P-III CAPSTONE-2 assessing Xofluza vs placebo & oseltamivir (75 mg) in 2,184 patients with high risk of complications from the influenza including asthma, chronic lung disease, morbid obesity or heart disease, aged > 12yrs. The P-III CAPSTONE-2 study results: reduction in improvement time of symptoms (74.6 hrs. vs […]Read More
Shots: The filling is based on results of P-III SOLO-1 study assessing Lynparza (300mg bid) vs PBO as a monothx in 391 newly-diagnosed patients with BRCA-m advanced ovarian cancer in ratio (2:1) for up to two years The study showed improved results with reduction in the risk of disease progression or death by 70%, remained […]Read More
Shots: The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs. P-II/III EXPRESS study results: @2 wks. change in weekly number of cataplexy attacks, change in EDS; @47 wks. increment in weekly cataplexy attacks (0.3 vs 12.7); no new safety signals observed published in […]Read More
Shots: The sNDA application is based on results of P-III iLLUMINATE (PCYC-1130) trial assessing Imbruvica (420) + Obinutuzumab (1000) vs chlorambucil (Days 1 & 15) + obinutuzumab (1000) over 6 cycles in patients with 1L CLL/SLL The iLLUMINATE study demonstrated 1EP as PFS, which showed longer PFS rate for Imbruvica + Obinutuzumab vs chlorambucil + […]Read More
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