dm+d
38221711000001102
New Medicines
Polivy
Diffuse large B-cell lymphoma (DLBCL) - first-line with chemotherapyInformation
Polivy
Licence extension / variation
Roche
Roche
Development and Regulatory status
None
Recommended for approval (Positive opinion)
Phase III Clinical Trials
Apr 22
Roche delays filing in the US to mid-2022 as the FDA has asked to see additional PFS data from the ongoing PIII Polarix trial. With the PFS data already announced, Roche and industry watchers have predicted that Polivy could become the new standard of care [10].
Mar 22
Recommended for EU approval by CHMP “for use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL)” [9].
Nov 21
Pre-registration in the EU. The EMA CHMP starts a review of an MAA for extension of the indication to include use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, is indicated for the treatment of adult patients with previously untreated DLBCL based on the efficacy and safety data from the pivotal PIII study GO39942 (POLARIX). This submission fulfils SOB003 thus supporting the switch from CMA to full MA [8].
Jul 18
Filings planned for 2021 or later [2].
Category
Anti-CD79B antibody–drug conjugate
The two most common types of NHL are DLBCL and follicular lymphomas. The overall annual incidence of DLBCL in Europe is 3.8/100,000 but the incidence increases with age and varies considerably across Europe [1].
Diffuse large B-cell lymphoma (DLBCL) - first-line with chemotherapy
Intravenous infusion
Further information
Yes
Trial or other data
Dec 21
PIII POLARIX RCT (n=879) found risk of disease progression, relapse, or death was lower among those who received modified regimen of R-CHOP (pola-R-CHP) in which vincristine replaced with polatuzumab, vs. those who received R-CHOP (PFS was 76.7% vs 70.2% at 2 years, HR 0.73; 95% CI, 0.57-0.95;p=0.02) [7].
Aug 21
Genentech announce the PIII POLARIX trial comparing polatuzumab vedotin in combination with chemotherapy regimen R-CHP versus the standard of care R-CHOP in treatment of first-line diffuse large B-cell lymphoma (DLBCL) met its primary endpoint of investigator assessed progression-free survival. Safety outcomes were consistent with those seen in previous trials. Results will be presented at an upcoming medical meeting and submitted to health authorities [6].
Jan 21
POLARIX study is recruiting again, including in the UK and Europe. Collection of primary outcome data should complete Jan 21 [5].
Jun 19
Recruitment complete in PIII POLARIX [4].
Jul 18
PIII POLARIX study due to complete collecting primary outcome data in Dec 19 [3].
Nov 17
PIII POLARIX trial to compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated DLBCL starts (NCT03274492). The double-blind, parallel, prospective, randomised trial is enrolling approximately 875 patients in the US and may extend to Taiwan [2].
Evidence based evaluations
Polivy
Relapsed or refractory diffuse large B-cell lymphoma (DLBL) - in combination with rituximab, gemcitabine and oxaliplatinInformation
Polivy
Licence extension/variation
Roche
Genentech
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Category
Anti-CD79B antibody–drug conjugate
The two most common types of NHL are DLBCL and follicular lymphomas. The overall annual incidence of DLBCL in Europe is 3.8/100,000 but the incidence increases with age and varies considerably across Europe
Relapsed or refractory diffuse large B-cell lymphoma (DLBL) - in combination with rituximab, gemcitabine and oxaliplatin
Intravenous infusion