Regulatory Decision Summary for Minjuvi

The authorization of Minjuvi (tafasitamab for injection) was based on 1 open-label, single-arm, multi-centre study that enrolled 81 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or arising from low-grade lymphomas (L-MIND). Patients had received 1 to 3 prior systemic treatment regiments and were ineligible for, or refused, autologous stem cell transplant (ASCT). Patients (n = 81) with relapsed or refractory DLBCL received up to 12 cycles, each 28-days long, of weekly Minjuvi in combination with lenalidomide, administered daily for the first 21-days of each cycle. After a maximum of 12 cycles of combination treatment, patients who did not progress continued to receive tafasitamab as monotherapy until disease progression or unacceptable toxicity.

The clinical benefit of tafasitamab in combination with lenalidomide was characterized by the best Overall Response Rate (ORR), which consists of all complete and partial responses, observed in a single-arm study. In the L-MIND study, a clinically meaningful ORR of 53.5% was observed. The Complete Response rate, was 35.2%, which was considered substantial in this relapsed or refractory population. Overall, responses were durable with an estimated median duration of response of 34.6 months. 

The most common adverse reactions associated with tafasitamab in combination with lenalidomide, based on the L-MIND study and reported in at least 30% of patients, were neutropenia, anemia, thrombocytopenia, asthenia, diarrhea, and respiratory tract infection. The product monograph for Minjuvi includes a boxed warning to alert patients and health professionals to the potential for infections, myelosuppression, progressive multifocal leukoencephalopathy and hepatitis B-reactivation. Infusion related reactions and tumour lysis syndrome are additional risks associated with this combination regimen. The combination of tafasitamab and lenalidomide is not recommended for use in treating pregnant females due to the risk of fetal B-cell depletion posed by Minjuvi as well as the known teratogenicity associated with lenalidomide. 

The recommended dosing regimen is Minjuvi, 12 mg/kg, administered by intravenous infusion on days 1, 8, 15 and 21 of every 28 day cycle for up to 12 cycles. During the first cycle, Minjuvi should also be administered on Day 4. After cycle 4, Minjuvi 12 mg/kg, should be administered by intravenous infusion on day 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Minjuvi is administered in combination with lenalidomide. The recommended dose of lenalidomide is 25 mg taken by mouth once per day for the first 21 days of each 28-day cycle for up to 12 cycles. The lenalidomide product monograph should be consulted for information regarding dose adjustments and the risks associated with lenalidomide treatment. 

Health Canada granted this application advanced consideration under the Notice of Compliance with Conditions policy. As a condition of authorization, the sponsor committed to file phase 3 trial data to confirm the efficacy of Minjuvi and the benefit/risk balance in patients