June 2026: CHMP Signals New Options in CLL, TNBC and Multiple Myeloma

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued positive opinions for three oncology and hematology therapies, setting up potential changes in how clinicians across Europe treat chronic lymphocytic leukemia, metastatic triple‑negative breast cancer and relapsed or refractory multiple myeloma.

Pirtobrutinib moves toward broader CLL use

CHMP has backed Eli Lilly’s BTK inhibitor pirtobrutinib (Jaypirca) for wide use in adults with chronic lymphocytic leukemia, covering both newly diagnosed and previously treated patients, including those who have already received covalent BTK inhibitors. This recommendation reflects data from two key Phase 3 studies in the BRUIN program.

In BRUIN CLL‑313, investigators compared once‑daily pirtobrutinib monotherapy with bendamustine plus rituximab in previously untreated CLL or small lymphocytic lymphoma without 17p deletions. The 282‑patient trial uses progression‑free survival assessed by independent review as its main outcome measure.

BRUIN CLL‑314 evaluates pirtobrutinib head‑to‑head against ibrutinib in 662 patients who are BTK inhibitor naive, including both treatment‑naive and previously treated individuals. Overall response rate by central review is the primary endpoint, with multiple secondary endpoints focused on time‑to‑event outcomes and tolerability. Together, these trials support expanding pirtobrutinib beyond the relapsed and refractory setting where BTK inhibitors have traditionally been used.

Datopotamab deruxtecan recommended for first‑line TNBC without immunotherapy

AstraZeneca and Daiichi Sankyo have secured a positive opinion for datopotamab deruxtecan (Datroway), a TROP2‑directed antibody drug conjugate, as first‑line monotherapy in adults with unresectable or metastatic triple‑negative breast cancer who are not candidates for PD‑1 or PD‑L1 inhibitor therapy. If the European Commission confirms the recommendation, Datroway would bring a new ADC approach into the front‑line TNBC setting for patients who currently depend on chemotherapy alone.

The TROPION‑Breast02 Phase 3 trial provides the evidence base. In this study, Datroway extended median overall survival to 23.7 months compared with 18.7 months for investigator’s choice chemotherapy, a five‑month absolute gain. The ADC also reduced the risk of progression or death by about 43 percent and delivered higher response rates, with objective responses in more than 60 percent of treated patients versus less than 30 percent in the chemotherapy arm.

These efficacy results, along with a safety profile consistent with prior experience, support Datroway as a potential new standard for immunotherapy‑ineligible metastatic TNBC.

Teclistamab plus daratumumab pushed into earlier myeloma lines

Johnson & Johnson’s BCMA‑targeting bispecific antibody teclistamab (Tecvayli) has received a CHMP recommendation for use in combination with subcutaneous daratumumab in adults with relapsed or refractory multiple myeloma after at least one prior line of therapy. Teclistamab is already approved in Europe for heavily pretreated patients, and this new opinion supports moving the bispecific and CD38 antibody combination into earlier relapse.

The MajesTEC‑3 Phase 3 trial underlies the recommendation. Researchers randomized patients who had received one to three prior regimens to receive either teclistamab plus daratumumab or daratumumab‑based triplets that included pomalidomide or bortezomib.

At around three years of follow‑up, the combination cut the risk of progression or death by more than 80 percent compared with the control regimens, with estimated 36‑month progression‑free survival of 83.4 percent in the combination arm versus 29.7 percent for standard therapy. Overall survival also favored teclistamab plus daratumumab, with three‑year survival above 80 percent compared with roughly two thirds of patients in the control group.