Jul 22 · Incyte withdraw filing for parsaclisib in EU, as it is not able to satisfactorily address concerns raised by CHMP, namely regarding study design and the feasibility of conducting further studies [9].

Jan 22 · Incyte withdraws parsaclisib for marginal zone lymphoma (MZL), follicular lymphoma (FL) and mantle cell lymphoma in business decision. The withdrawal affects the said three indications in the US and is not associated with any changes in the drug´s safety or efficacy. It also does not have an impact on other ongoing studies on parsaclisib in the US and other locations. [8]

Jan 22 · Incyte withdraws parsaclisib for marginal zone lymphoma (MZL), follicular lymphoma (FL) and mantle cell lymphoma in business decision. The withdrawal affects the said three indications in the US and is not associated with any changes in the drug´s safety or efficacy. It also does not have an impact on other ongoing studies on parsaclisib in the US and other locations. [8]

Dec 21 · Filed in EU via centralised procedure [7].

Nov 21 · US filings based on data from several phase II trials (CITADEL-203, -204 and -205). The Prescription Drug User Fee Act (PDUFA) target action date for MZL and MCL is April 30, 2022. The NDA for parsaclisib treatment in adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies will follow Standard Review and a PDUFA target action date of August 30, 2022 [5].

Nov 21 · US FDA accept NDA for parsaclisib for relapsed or refractory follicular lymphoma, marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). Priority Review has been granted for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with MCL who have received at least one prior therapy [5].

There are around 14,100 new non-Hodgkin lymphoma cases in the UK every year [1]. Marginal zone lymphomas (MZLs) account for between 5% and 17% of all NHL. MZLs consist of 3 different subtypes with extranodal being the most commonly reported, representing 50-70% of MZL, followed by splenic (20%) and nodal (10%) [2].

Dec 21 · PII studies, CITADEL-203, 204 and 205, are all active and have finished recruiting. Collection of primary outcome data completed in all three studies in Jan 21. Results released show that in CITADEL-203 trial, treatment with parsaclisib demonstrated overall response rate of 75% in daily dosing group (DG) (n=95), and 73% in overall patients (n=118), with follicular lymphoma. The median duration of response (DOR) was reported to be 14.7 and 15.9 months in the DG and overall group. The median progression free survival (PFS) was reported to be 15.8 months each in both groups. In CITADEL-204 trial, treatment with parsaclisib demonstrated an objective response rate of 54.3% overall and 57.6% in DG, the ORR was 48.3%, 50.0%, and 63.6% for patients with nodal, extranodal, and splenic MZL, respectively. The median time to response was reported to be eight weeks. In CITADEL-205 trial for a cohort of BTK inhibitor-naïve patients (n=104) with R/R MCL, parsaclisib demonstrated an ORR and complete response rate (CRR) of 66.3% and 15.2%, respectively in all evaluable patients, and were 65.6% and 11.5% for the DG. Median time to response for patients with a complete or partial response was 7.9 weeks. The median DOR was 11.0 months for all responders and 9.0 months for DG. Median PFS was 11.1 months overall, and 11.1 months for DG [5,6].

Feb 21 · PII CITADEL-204 continues [3].

Dec 19 · Recruitment completes in PII CITADEL-204 study [3].

Dec 17 · PII CITADEL-204 study to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton´s tyrosine kinase (BTK) inhibitor starts (NCT03144674). 11 adults will be recruited in countries including the UK and US, plus Europe. Primary outcome is objective response rate; collection of these data is due to complete Jan 22 [3].

Nov 17 · PII CITADEL-205 study to evaluate the safety and efficacy of parsaclisib in participants diagnosed with relapsed or refractory mantle cell lymphoma starts (NCT03235544). Primary outcome is objective response rate; collection of these data is due to complete Mar 21 [4].

Jun 17 · PII CITADEL-203 study to evaluate the safety and efficacy of parsaclisib with idelalisib in participants diagnosed with relapsed or refractory follicular lymphoma starts (NCT03126019). Primary outcome is objective response rate; collection of these data is due to complete Feb 21 [4].