EC approves Lynozyfic for treatment of r/r multiple myeloma

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

Teclistamab improves outcomes in relapsed MM, phase III trial finds

An international phase III study showed that patients with relapsed multiple myeloma treated with teclistamab lived longer and remained in remission significantly longer than patients receiving standard therapies.

June 05, 2026

Vol.52 No.22

Drugs & Targets

European Commission authorizes expanded label for Venclyxto to include additional combinations in previously untreated CLL

The European Commission authorized an expanded label for Venclyxto (venetoclax) to include use in combination with acalabrutinib (with or without obinutuzumab) and use in combination with ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia.

June 05, 2026

Vol.52 No.22

Drugs & Targets

EU approves Ojemda as first targeted therapy in r/r pediatric low-grade glioma regardless of BRAF alteration

The European Commission has granted conditional marketing authorization for Ojemda (tovorafenib) as monotherapy for the treatment of patients 6 months of age and older with pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.

April 24, 2026

Vol.52 No.16

Guest Editorial

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.” This release came roughly 20 months after the Oncologic Drugs Advisory Committee (ODAC) voted unanimously that minimal residual disease (MRD) negativity, in combination with complete response (CR), is an acceptable primary endpoint to support accelerated approval for multiple myeloma (MM) therapies.

April 03, 2026

Vol.52 No.13

By Nicholas Richardson

EC approves Lynozyfic for treatment of r/r multiple myeloma

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

EC approves Maviret for the treatment of acute HCV

Teclistamab improves outcomes in relapsed MM, phase III trial finds

European Commission authorizes expanded label for Venclyxto to include additional combinations in previously untreated CLL

EU approves Ojemda as first targeted therapy in r/r pediatric low-grade glioma regardless of BRAF alteration

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

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EC approves Lynozyfic for treatment of r/r multiple myeloma

YOU MAY BE INTERESTED IN

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

EC approves Maviret for the treatment of acute HCV

Teclistamab improves outcomes in relapsed MM, phase III trial finds

European Commission authorizes expanded label for Venclyxto to include additional combinations in previously untreated CLL

EU approves Ojemda as first targeted therapy in r/r pediatric low-grade glioma regardless of BRAF alteration

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters mostDraft guidance consolidates trial design updates for developers

Never miss an issue!

Login

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers