Tags : Health Canada

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment

Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are […]Read More

Merck’s Brenzys (etanercept, biosimilar) Receives Health Canada Approval for Multiple

Shots: Health Canada has approved Brenzys for new indications that include adults & pediatric patients (4-17yrs.) with PsO who are candidates for systemic therapy/ phototherapy, adult patients with PsA, and patients aged 4-17yrs. with JIA The clinical efficacy and safety studies conducted in patients with RA demonstrate clinical comparability between Brenzys and the reference product. […]Read More

Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe

Shots: The Health Canada has approved a new indication as an add-on maintenance treatment with intranasal corticosteroids in patients with CRSwNP, inadequately controlled by systemic corticosteroids or surgery The approval is based on P-III studies (24wks. SINUS-24 and 52wks. SINUS-52) assessing Dupixent (300mg, q2w) + SOC intranasal corticosteroids vs PBO + intranasal corticosteroids. The studies […]Read More

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health

Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & […]Read More

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the

Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile […]Read More