BeiGene has secured the approval of the US Food and Drug Administration (FDA) for the company’s Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Brukinsa FDA approval is backed by the findings of two global phase 3 clinical trials wherein Brukinsa showed superior efficacy and […]
Natco Pharma Limited said that a US District Court has given a decision in favor of Pharmacyclics, a subsidiary of AbbVie, the brand owner of Imbruvica (ibrutinib) in a PIV litigation that involved the cancer drug. The Indian pharma company said that it will review the judgment and assess all options for appealing the judgment, […]
AbbVie said that the phase 3 GLOW study in chronic lymphocytic leukemia (CLL) investigating the combination of IMBRUVICA (ibrutinib) plus VENCLEXTA/VENCLYXTO (venetoclax) (I+V) has met its primary endpoint of superior progression-free survival (PFS). The GLOW clinical trial is comparing the efficacy and safety of the ibrutinib, venetoclax combination against chlorambucil plus obinutuzumab (C+O) for first-line […]
Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has received approval from the US Food and Drug Administration (FDA) for its combination treatment of IMBRUVICA (ibrutinib) and rituximab for Waldenström’s macroglobulinemia (WM), a rare form of blood cancer. This latest approval expands the use of IMBRUVICA in treating WM from monotherapy to now include combination […]