EU agencies have backed wider use of three oncology drugs. The new EMA CHMP oncology approvals add fresh combo regimens. They also broaden options for blood cancer patients.

The April 2026 EMA CHMP oncology approvals affect Inaqovi, Opdivo, and Venclyxto. The Committee for Medicinal Products for Human Use (CHMP), part of the EMA, issued positive opinions on each drug. Each label now covers a broader range of blood cancers. The covered diseases are acute myeloid leukaemia (AML), classical Hodgkin lymphoma (cHL), and chronic lymphocytic leukaemia (CLL). The new uses target patients unfit for standard care. Some need earlier treatment.

Inaqovi gains a new combo role in AML

Inaqovi (decitabine/cedazuridine, Otsuka) now has a new indication. It can be paired with venetoclax. The combo is for adults with newly diagnosed AML who are unfit for standard induction chemotherapy.

AML is a fast-moving blood cancer. It blocks blood cell growth. Older or frail patients fare worst.

Inaqovi is an oral hypomethylating agent. It pairs two drugs. The first is decitabine. It inhibits DNA methyltransferase. The second is cedazuridine. It inhibits cytidine deaminase. It also lifts levels of decitabine. Venetoclax is a BCL-2 inhibitor. It adds a second mode of attack. The drugs together kill leukemic blasts.

A phase 2 study tested the combo in newly diagnosed AML patients unfit for intensive chemotherapy. Complete response rates reached 46%. Composite response rates hit 63%.

Opdivo gets a frontline role in classical Hodgkin lymphoma

Opdivo (nivolumab, Bristol Myers Squibb) earned a new indication. It can now be combined with doxorubicin, vinblastine, and dacarbazine (AVD). The combo is for adults and teens aged 12 years or older. They must have previously untreated stage III or IV cHL.

Nivolumab is an immune checkpoint inhibitor. It blocks the PD-1 receptor. That restores T-cell-mediated antitumor immunity. cHL features Reed-Sternberg cells. These cells often overexpress PD-L1. So checkpoint blockade fits the disease.

The new EMA CHMP oncology approvals for Opdivo build on phase 3 evidence. Adding nivolumab to AVD in frontline therapy improved progression-free survival (PFS) over standard regimens.

The pivotal trial was SWOG 1826. There, nivolumab plus AVD beat the older AVD combo. Brentuximab vedotin sat in the comparator arm. The risk of disease growth or death fell about 58% (hazard ratio, 0.42). Longer follow-up showed lasting benefit. The nivolumab arm saw fewer deaths.

Venclyxto adds new fixed-duration CLL combos

Venclyxto (venetoclax, AbbVie) got a positive opinion. The change broadens its use in adults with previously untreated CLL. The label now covers new fixed-duration pairings with Bruton tyrosine kinase (BTK) inhibitors.

The newly approved fixed-duration regimens are:

• Venclyxto plus acalabrutinib, with or without obinutuzumab
• Venclyxto plus ibrutinib

CLL is slow-moving but incurable. Care is shifting toward targeted, chemo-free regimens.

Venclyxto is a selective BCL-2 inhibitor. It blocks the anti-apoptotic BCL-2 protein. That triggers apoptosis. CLL cells overexpress that protein. The protein helps them survive.

Acalabrutinib and ibrutinib are BTK inhibitors. They block B-cell receptor signalling. Obinutuzumab is an anti-CD20 antibody. It drives B-cell loss.

Two trials back the new pairings. The phase 3 AMPLIFY trial showed that fixed-duration acalabrutinib-venetoclax, with or without obinutuzumab, improved PFS over chemoimmunotherapy in CLL. The phase 2 CAPTIVATE study sent similar signals. First-line fixed-duration ibrutinib plus venetoclax led to strong, lasting responses. PFS held up at long follow-up.

The CHMP did not cite a single supporting trial. The change reflects a wider trend. The new EMA CHMP oncology approvals show that fixed-duration, chemo-free regimens now sit at the heart of deep and durable CLL responses.

What happens next

Detailed dosing guidance will follow in the updated Summary of Product Characteristics. The documents will appear on the EMA website in every official language of the European Union. Publication is on hold pending European Commission approval of the label changes.

These EMA CHMP oncology approvals matter beyond the data. Coverage on Medigear.uk shows why hospital teams, dealers, and clinic owners must track how these EMA CHMP oncology approvals reshape blood cancer care in 2026.

Source: Originating coverage of the European Medicines Agency CHMP April 2026 meeting opinions on Inaqovi, Opdivo, and Venclyxto. Official documentation: European Medicines Agency (EMA) — Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), April 2026 — https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights