Tags : Mantle Cell Lymphoma

Kite’s KTE-X19 Receives the US FDA’s Priority Review for Relapsed

Shots: The US FDA has accepted BLA and granted PR designation to Kite’s KTE-X19 for the treatment of patients with r/r MCL The BLA is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18yrs. with r/r MCL following up to prior 5L therapies including an anthracycline, bendamustine-containing CT, anti-CD20 mAb and the […]Read More

Kite Reports the Validation of EMA’s MAA for KTE-X19 to

Shots: The MAA is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18yrs. with MCL whose diseases is refractory & relapsed following up to five prior therapies including anthracycline/ bendamustine-containing CT, anti-CD20 mAb and the BTK inhibitors (ibrutinib/ acalabrutinib) The P-II ZUMA-2 study results: ORR (93%); CR (67%) as assessed by IRRC […]Read More

AstraZeneca Canada’s Calquence (acalabrutinib) Receives Health Canada Approval for Patients

Shots: The NOC is based on the positive data of Calquence in ACE-LY-004 trial demonstrating 81% OR rate for patients with relapsed or refractory MCL The Health Canada approval of Calquence allows AstraZeneca to develop the treatments of blood cancers Calquence (acalabrutinib, previously known as ACP-196) is an oral selective inhibitor of Bruton’s tyrosine kinase (BTK) […]Read More

Beigene’s Zanubrutinib (BGB-3111) Receives the US FDA’s Breakthrough Therapy Designation

Shots: The BT designation follows the P-II trial assessing Zanubrutinib in patients with 1L mantle cell lymphoma Beigene’s Zanubrutinib is being evaluated globally in seven P-III trials in multiple areas including one for patients with waldenstrom macroglobulinemia (WM) with zanubrutinib vs ibrutinib and P-II for r/r follicular lymphoma in combination with Gazyva (obinutuzumab) Zanubrutinib (BGB-3111) […]Read More