Tags : 1L

BMS Reports the US FDA Acceptance of sBLA for Opdivo

Shots: The US FDA has accepted sBLA for the dual regimen as 1L treatment for metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations and has granted the PR status to the therapy The application is based on part 1 of P-III CheckMate -227 study results assessing Opdivo + Yervoy vs platinum-doublet […]Read More

Merck & Co Reports Results of Keytruda in P-III KEYNOTE-604

Shots: The P-III KEYNOTE-604 study involves assessing of Keytruda (pembrolizumab, 200 mg) + etoposide + Pt CT vs PBO + etoposide +PT CT in 453 patients newly diagnosed with ES-SCLC The P-III study resulted in improvement in PFS and OS but the OS results did not meet statistical significance per the pre-specified statistical plan, safety […]Read More

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s

Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks […]Read More

AstraZeneca and Merck & Co Receive the US FDA Advisory

Shots: The US FDA’s ODAC voted 7 to 5 in favor of recommending Lynparza as 1L maintenance monotherapy for patients with gBRCAm metastatic adenocarcinoma of the pancreas that has not progressed on 1L platinum-based CT The ODAC recommendation is based on P-III POLO study assessing Lynparza vs PBO in 154 patients in a ratio (3:2) […]Read More

AstraZeneca and MSD’s Lynparza (olaparib) Receive NMPA’s Approval as 1L

Shots: The approval is based on P-III SOLO-1 study assessing Lynparza (bid, 300mg) as maintenance therapy vs PBO in 391 patients in a ratio (1:1) with a deleterious or suspected deleterious germline or somatic BRCA/BRCA2 mutated ovarian cancer following 1L platinum-based CT The P-III SOLO-1 study result: reduction in disease progression or death by 70%; […]Read More

Takeda Reports Results of Ninlaro (ixazomib) in P-III TOURMALINE-MM4 Study

Shots: The P-III TOURMALINE-MM4 study involves assessing Ninlaro (ixazomib) as 1L maintenance therapy vs PBO in 706 newly diagnosed patients with multiple myeloma not treated with stem cell transplantation with completed 6-12mos. of initial therapy and achieved a partial response or better The P-III TOURMALINE-MM4 study results demonstrated significant improvement in PFS with consistent safety […]Read More

BMS Reports Result of Opdivo (nivolumab) + Yervoy (ipilimumab) +

Shots: The P-III CheckMate -9LA study involve assessing of Opdivo (360mg q3w) + Yervoy (1mg/kg q6w) combined with CT (two cycles) vs CT as monothx. (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with advanced NSCLC regardless of PD-L1 expression and histology The P-III CheckMate […]Read More