A panel of the European Medicines Agency (EMA) recommended the expanded approval of Bristol Myers Squibb’s (NYSE:BMY) Breyanzi to treat adult patients with certain types of blood cancer in an earlier setting.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Breyanzi to treat adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of or are refractory to first-line chemoimmunotherapy.
Breyanzi (lisocabtagene maraleucel / lisocabtagene maraleucel) a CAR T cell therapy is already approved in the EU to treat adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.
The CHMP decision was backed by data from a phase 3 trial called TRANSFORM.
“This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers.
The European Commission (EC), which generally follows the opinion of the CHMP, will now make a decision on the application.
by: Seeking Alpha
published on Seeking Alpha