Roche’s blood cancer portfolio is booming with new life thanks to the antibody-drug conjugate Polivy and bispecifics. Now, the company is offering a look at early-phase data for two combinations of those drugs that support two phase 3 trials in diffuse large B-cell lymphoma (DLBCL).
The FDA approved Roche and Genentech’s antibody-drug conjugate Polivy in April as a first-line treatment for diffuse large B-cell lymphoma (DLBCL) alongside a chemotherapy regimen R-CHP.
After a regulatory scare, Roche can now kick off work on changing nearly 20 years of clinical practice for the treatment of diffuse large B-cell lymphoma (DLBCL).
An FDA committee of outside cancer experts voted 11-2 Thursday that the FDA should expand Roche’s Polivy label to include it as a treatment in combo with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
An FDA advisory committee is meeting on Thursday to weigh a potential label expansion for Roche’s potential blockbuster Polivy, but the agency has some concerns about efficacy and safety.
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy® (polatuzumab vedotin-piiq) were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, December 10-13. Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).
Swiss pharma giant Roche (ROG: SIX) has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab).
Genentech, a part of the Roche Group, says the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy.
The European Commission (EC) has granted approval of Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients with previously untreated Diffuse Large B-Cell Lymphoma (DLBCL), Roche said yesterday in a statement.