The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of conditional marketing authorization of Tepkinly (epcoritamab), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, after two or more lines of systemic therapy.
FDA approved Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Commission approved Fruzaqla (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.
eHealth Technologies, a healthcare technology company, will join CancerX, a public-private partnership acting as a national accelerator, to boost innovation in the fight against cancer.
Merck Global Health Innovation Fund has made a strategic investment into Qure.ai as part of its Series D round.
FDA approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
Patients treated with CAR T-cell medicines should be monitored life-long for secondary malignancies.
Zymeworks Inc., a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, announced that FDA has cleared the investigational new drug application for ZW171, a novel 2+1 T-cell targeting bispecific antibody for mesothelin-expressing cancers.
FDA approved lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
