relapsed or refractory chronic lymphocytic leukaemia progression after 12 months vs. 68% for comparators AstraZeneca s Calquence (acalabrutinib), a next-generation, selective Bruton s tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]). The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ASCEND Phase III trial and a Phase I trial in Japanese patients, showing Calquence monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus a standard treatment of rituximab, a monoclonal antibody, combined with the physician s choice of idelalisib, a PI3-kinase inhibitor or bendamustine, a chemotherapy.
against ibrutinib in chronic lymphocytic leukaemia Superior safety on key secondary endpoint of atrial fibrillation Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib. The trial also met a key secondary endpoint for safety, showing patients treated with Calquence had statistically significantly lower incidence of atrial fibrillation compared to patients treated with ibrutinib. Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications .
1 Further hierarchical testing revealed no difference for Grade 3 or higher infections or Richter s transformation. There was a descriptive trend for numerically fa
TORONTO, Jan. 20, 2021 (GLOBE NEWSWIRE) Auxly Cannabis Group Inc. (“
Auxly” or the “
Company”) (TSXV: XLY) (OTCQX: CBWTF) is pleased to announce that it has entered into an agreement pursuant to which ATB Capital Markets Inc. and Cantor Fitzgerald Canada Corporation, as co-lead underwriters and joint bookrunners, together with a syndicate of underwriters (collectively, the “
Underwriters”), will purchase 40,550,000 Units of the Company (the “
Units”), on a bought-deal basis at a price per Unit of $0.37 (the “
Issue Price”) for gross proceeds of $15,003,500 (the “
Offering“).
Each Unit shall be comprised of one common share of the Company (each a “
Common Share“) and one-half of one Common Share purchase warrant of the Company (each whole warrant, a “
previously treated HER2-positive advanced gastric cancer AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
In the US, gastric cancer is most frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving beyond five years.
1,2 Approximately one in five gastric cancers are HER2 positive.
3
The approval by the Food and Drug Administration (FDA) was based on the positive results from the randomised DESTINY-Gastric01 Phase II trial conducted in Japan and South Korea. In the trial, Enhertudemonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and objective respo
Imfinzi approved in the EU for less-frequent, fixed-dose use in unresectable non-small cell lung cancer pressreleasepoint.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pressreleasepoint.com Daily Mail and Mail on Sunday newspapers.