dm+d

38221711000001102

New Medicines

PolivyDiffuse large B-cell lymphoma (DLBCL) - first-line with chemotherapy

Information

Polivy
Licence extension / variation
Roche
Roche

Development and Regulatory status

Launched
Launched
Pre-registration (Filed)
Yes
Aug 22Roche has filed in the US for use of Polivy and Rituxan, plus cyclophosphamide, doxorubicin and prednisone, in patients with previously untreated DLBCL. The FDA has set a regulatory action date of April 2, 2023 [14].
Jul 22Approved in UK and granted Orphan status. Full indication is ´Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL)´ [13].
May 22Approved in EU [12].
Apr 22Roche 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 22Recommended 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 21Pre-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 18Filings 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

Jan 22POLARIX published in NEJM [11].
Dec 21PIII 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 21Genentech 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 21POLARIX study is recruiting again, including in the UK and Europe. Collection of primary outcome data should complete Jan 21 [5].
Jun 19Recruitment complete in PIII POLARIX [4].
Jul 18PIII POLARIX study due to complete collecting primary outcome data in Dec 19 [3].
Nov 17PIII 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

PolivyRelapsed or refractory diffuse large B-cell lymphoma (DLBL) - in combination with rituximab, gemcitabine and oxaliplatin

Information

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