Shots: The P-II CheckMate -650 trial involves assessing of Opdivo (nivolumab, 1mg/kg) + Yervoy (ipilimumab, 3mg/kg) in patients with mCRPC P-II study result in asymptomatic or minimally symptomatic patients & patients who progressed after taxane-based CT ORR @ 11.9/13.5 mos. (25%, 10%); GRADE 3AEs or 5AEs (42%, 53%), Presented at ASCO 2019 Opdivo (nivolumab) is […]Read More
Shots: The P-III CheckMate-214 study involves assessing of Opdivo (nivolumab, 3mg/kg) + Yervoy (ipilimumab,1mg/kg) vs sunitinib (50mg qd @4wks.) in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) P-III Checkmate study results @30 months: OS (60% vs 47%); ORR (42% vs 29%); CR (11% vs 1%), @ intention-to-treat (ITT): OS (64% vs […]Read More
Shots: The expansion approval is based on the CA180-372 (NCT01460160) P-II study results assessing Sprycel (qd, 60 mg/m @24 mos.) + CT in 78 patients with Ph+ ALLaged 2 to 10 yrs. The P-II CA180-372 study demonstrated as an effective treatment with EFS binary rate 64.1% in patients with newly diagnosed B-cell precursor Ph+ ALL […]Read More
Shots: Taisho to acquire BMS’ UPSA Consumer Health Business for $1.6B, in all stock transaction with the put option. The transaction is expected to close in H1’19 The focus of the agreement is to allow BMS to emphasize on its portfolio offering treatments in serious diseases and strengthen Taisho’s OTC platform UPSA develops and delivers medicines in multiple therapeutic […]Read More
Shots: The CHMP (EMA) recommendation is based on P-II CA180-372 (NCT01460160) study assessing Sprycel + CT in pediatric patients with newly diagnosed +ve acute lymphoblastic leukemia (ALL) Sprycel received the US FDA’s and EU’s approval to treat pediatric patients with +ve chronic myeloid leukemia in chronic phase (CML-CP) in Nov, 2017 & July, 2018 respectively Sprycel is a tyrosine kinase inhibitor, […]Read More
Shots: The P-III Checkmate-451 involves assessing Opdivo (nivolumab, 1mg/kg) + Yervoy (ipilimumab,3 mg/kg) vs PBO as a maintenance therapy in patients with extensive-stage small cell lung cancer (SCLC) The study demonstrated unmet 1EPs & 2EPs as OS with no new safety signals observed in patients Opdivo is an PD-1 inhibitor indicated to treat multiple cancer […]Read More
Shots: This sBLA involves (Sprycel + CT) for the treatment of pediatric patients (≤17yrs) newly diagnosed with Philadelphia chromosome +ve ALL The application is based on the ongoing P-II CA180-372 (NCT01460160) trial evaluating (Sprycel + CT) modeled on a Berlin-Frankfurt-Munster high-risk backbone in patients with Ph+ ALL Expected Action date by FDA is Dec 29, […]Read More
Shots: Approval is based ongoing Ph 1/2 CheckMate-032, study is assessing 245 patients in two arms Opdivo vs platinum based therapy CheckMater-032 Results: ORR:12% (13/109); PR: 11% (12/109); CR: 0.9% (1/109); mDOR: 17.9 mos; SAE: 45% Approved dose for Opdivo for SCLC is 240mg IV Q2W until disease progression or unacceptable toxicity Click here to […]Read More
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