European regulators have backed expanded use of three oncology therapies, introducing new combination regimens and extending treatment options for patients with hematologic malignancies.

At its April 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) issued positive opinions to update the marketing authorizations of Inaqovi, Opdivo, and Venclyxto. These changes expand therapeutic indications across hematologic malignancies, including acute myeloid leukemia (AML), classical Hodgkin lymphoma (cHL), and chronic lymphocytic leukemia (CLL), particularly in patients ineligible for standard therapies or in earlier lines of treatment.

Inaqovi 

Inaqovi (decitabine/cedazuridine, Otsuka) received a new indication in combination with venetoclax for treating adult patients with newly diagnosed AML who are ineligible for standard induction chemotherapy. 

AML is an aggressive clonal disorder of hematopoietic progenitors characterized by impaired differentiation and proliferation of myeloid cells, with poor outcomes in older or unfit patients.

Inaqovi is an oral hypomethylating agent combining decitabine — a DNA methyltransferase inhibitor — with cedazuridine, a cytidine deaminase inhibitor that increases systemic exposure of decitabine. The rationale for combining hypomethylating agents with BCL-2 inhibition (via venetoclax) is supported by synergistic induction of apoptosis in leukemic blasts.

Clinical data from a phase 2 study of decitabine/cedazuridine combined with venetoclax in patients with newly diagnosed AML who were ineligible for intensive chemotherapy showed complete response rates of approximately 46% and composite response rates of about 63%.

Opdivo 

Opdivo (nivolumab, Bristol Myers Squibb) was granted a new indication in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adults and adolescents aged ≥ 12 years with previously untreated stage III or IV cHL. 

Nivolumab is an immune checkpoint inhibitor that blocks the PD-1 receptor, restoring T-cell-mediated antitumor immunity. cHL is characterized by Reed-Sternberg cells that frequently overexpress PD-L1, making checkpoint inhibition a rational strategy. 

The addition of nivolumab to AVD chemotherapy in the frontline setting is supported by clinical trial data showing improved progression-free survival (PFS) compared with standard regimens.

In the phase 3 SWOG 1826 trial, nivolumab plus AVD significantly improved PFS compared with brentuximab vedotin plus AVD, reducing the risk of progression or death by about 58% (hazard ratio, 0.42). Durable benefit was observed with longer follow-up, with fewer deaths reported in the nivolumab arm.

Venclyxto 

Venclyxto (venetoclax, AbbVie) received a positive opinion expanding its use in previously untreated adult patients with CLL to include new fixed-duration combination regimens with Bruton tyrosine kinase (BTK) inhibitors. 

The newly added fixed-duration combination regimens include:

• Venclyxto in combination with acalabrutinib, with or without obinutuzumab
• Venclyxto in combination with ibrutinib

CLL is a typically indolent but incurable B-cell malignancy, with treatment strategies increasingly focused on targeted, chemotherapy-free regimens. 

Venclyxto is a selective BCL-2 inhibitor that promotes apoptosis by inhibiting the anti-apoptotic BCL-2 protein, which is overexpressed in CLL cells and contributes to their survival. 

BTK inhibitors such as acalabrutinib and ibrutinib block B-cell receptor signaling, while obinutuzumab is an anti-CD20 antibody that promotes immune-mediated B-cell depletion.

Evidence supporting these combinations includes the phase 3 AMPLIFY trial, which showed that fixed-duration acalabrutinib-venetoclax with or without obinutuzumab improved PFS compared with chemoimmunotherapy in previously untreated CLL.

Similarly, in the phase 2 CAPTIVATE study, first-line fixed-duration ibrutinib plus venetoclax demonstrated high response rates and durable remissions, including sustained PFS with long-term follow-up.

However, the CHMP did not identify specific supporting trials for any of the updated indications, which reflects a broader evolution of combination strategies rather than a single trial-driven change.

The expanded indications underscore a shift toward fixed-duration, chemotherapy-free regimens that combine BCL-2 inhibition with complementary targeted agents to achieve deep and durable responses in CLL.

Next Steps 

Detailed recommendations for use will be provided in the updated Summary of Product Characteristics, which will be published on the EMA website in all European Union official languages following European Commission approval of the variation to the marketing authorization.