Health ministry of Japan approves Sarclisa for MM

Mezigdomide + carfilzomib + dexamethasone regimen reduces disease progression in r/r MM, phase III trial finds

Mezigdomide, carfilzomib, and dexamethasone demonstrated a >50% reduction in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma compared to carfilzomib and dexamethasone, according to the results of the SUCCESSOR-2 phase III trial.

June 26, 2026

Vol.52 No.25

Drugs & Targets

FDA approves Tecelra for pediatric synovial sarcoma

FDA granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

June 26, 2026

Vol.52 No.25

Drugs & Targets

EC approves Padcev + Keytruda as perioperative treatment option for cisplatin-ineligible patients with resectable muscle-invasive bladder cancer

The European Commission granted Marketing Authorization for Padcev (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy in the European Union.

June 26, 2026

Vol.52 No.25

Drugs & Targets

EC approves Maviret for the treatment of acute HCV

The European Commission approved Maviret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral therapy for the treatment of acute hepatitis C virus infection in adults and children aged 3 years and older. With this approval, Maviret is now the only treatment approved in the European Union for both acute and chronic HCV infection.

June 26, 2026

Vol.52 No.25

Clinical Roundup

Talvey + Darzalez Faspro shows significant survival gains in r/r MM, phase III MonumenTAL-3 study finds

Talvey (talquetamab-tgvs), a GPRC5D bispecific antibody, in combination with Darzalez Faspro (daratumumab and hyaluronidase-fihj) with or without pomalidomide demonstrated significant reduction in the risk of disease progression or death of up to 72% and clinically meaningful reduction of up to 53% in the risk of death compared to the standard regimen of Darzalez Faspro, pomalidomide, and dexamethasone in patients with relapsed/refractory multiple myeloma, according to the results of the investigational phase III MonumenTAL-3 study.

June 18, 2026

Vol.52 No.24

Cancer Policy

FDA approves leucovorin for cerebral folate deficiency

FDA has approved leucovorin calcium tablets (Wellcovorin), expanding its use for the treatment of cerebral folate deficiency in adult and pediatric patients.

March 13, 2026

Vol.52 No.10

By Claire Marie Porter