CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab
pharmafile | June 29, 2021 | News story | Manufacturing and Production | CHMP, EMA, EU, FDA, US
Incyte and MorphoSys have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorisation of tafasitamab in combination with lenalidomide.
The drug is to be used in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).
The recommendation follows positive data from the L-MIND trial, a single arm, open-label Phase II study investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory DLBCL who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy who are not eligible for high-dose chemotherapy (HCD) or ASCT.
Steven Stein, Chief Medical Officer at Incyte, said: “The CHMP’s positive opinion of tafasitamab is a pivotal step towards addressing an urgent unmet medical need for the 30-40% of patients with relapsed or refractory DLBCL who do not respond to initial therapy or relapse thereafter.
“Following the US FDA’s approval of tafasitamab in July 2020, we eagerly await the European Commission’s decision as we look forward to bringing this new therapy to eligible patients in Europe as soon as possible.”
The CHMP opinion to recommend the use of tafasitamab is now being reviewed by the European Commission, which has the authority to grant marketing authorisation for medicinal products in the European Union. If approved, tafasitamab would be commercialized in the EU under the brand name MinjuviÒ.
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide comprising 40% of all cases and characterised by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow, or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter. In Europe, approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL each year.
Dr Malte Peters, Chief Research & Development Officer at MorphoSys, said: “Tafasitamab in combination with lenalidomide represents an important new targeted treatment option for patients with relapsed or refractory DLBCL.
“Patients with relapsed or refractory DLBCL have limited treatment options and often face a poor prognosis. There is an urgent need for effective therapies and if approved, this combination could provide patients in Europe with an important new therapeutic option.”
Incyte and MorphoSys share global development rights to tafasitamab and Incyte has exclusive commercialisation rights to tafasitamab outside the United States.
Kat Jenkins
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