Polivy · Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) - in combination with rituximab and bendamustine
Development and Regulatory status
Jun 19: Granted EAMS status in UK for use in combination with bendamustine and rituximab for treatment of relapsed/refractory DLBCL in adults who are not eligible for hematopoietic stem cell transplant .
Jun 19: Approved in the US and will cost about $99,000 for a course. The accelerated approval could be contingent on results from a confirmatory trial 
Feb 19: Filed in EU, under accelerated assessment programme [8,9].
Feb 19: BLA submitted to FDA for use in combination with rituximab and bendamustine, the FDA is expected to make a decision on approval by August 19, 2019 .
Dec 18: Granted orphan drug status in EU & US .
Apr 18: Filings for relapsed or refractory DLBCL now planned for 2018, and in 2021 for first-line use .
Oct 17: EU & US filings will be 2020 at the earliest .
Oct 17: Granted breakthrough therapy status in US .
Jun 17: Granted PRIME status In EU for use in combination with rituximab and bendamustine for the treatment of people with relapsed or refractory DLBCL .
Trial or other data
Dec 18: Roche announces longer-term data from the PIb/II GO29365 study showing that polatuzumab vedotin, in combination with rituximab plus bendamustine (BR), demonstrated a median overall survival (OS) of over one year compared to the BR arm (12.4 vs. 4.7 months, HR 0.42; 95% CI 0.24, 0.75), in people with R/R DLBCL not eligible for a haematopoietic stem cell transplant. OS was an exploratory endpoint. Adverse events (AEs) were consistent with those seen in previous studies of polatuzumab vedotin, and of BR, with no new safety signals observed. Treatment with polatuzumab vedotin plus BR resulted in a 66% reduction in risk of disease progression or death (as measured by investigator-assessed progression free survival; PFS; HR=0.34; 95% CI 0.2-0.570; p<0.0001), with 40% achieving a complete response (CR) compared to 18% in the BR arm (primary endpoint, as measured by positron emission tomography (PET); CR rates assessed by independent review committee; p=0.026). Furthermore, patients treated with polatuzumab vedotin plus BR achieved higher CR rates and longer PFS and OS compared with BR in all subgroups tested, including patients from cell-of-origin groups, germinal centre B-cell-like and activated B-cell-like, which are associated with a worse prognosis in DLBCL .
Dec 17: Genentech reports that the PII part of a PI/II trial met its primary endpoint (GO29365; NCT02257567). In the trial, the combination of polatuzumab vedotin and bendamustine, compared with bendamustine alone, significantly increased complete response rates in 225 patients with relapsed or refractory DLBCL in the US, Australia, Canada, Czech Republic, Germany, Hungary, South Korea, Spain and the UK .