EC approves Keytruda as adjuvant treatment for NSCLC at high risk of recurrence

Sigvotatug vedotin misses OS primary endpoint vs. docetaxel in phase III trial in previously treated metastatic non-squamous NSCLC

Sigvotatug vedotin, an integrin beta-6 directed antibody-drug conjugate, did not show a statistically significant improvement in the primary endpoint of overall survival, compared to docetaxel, according to the results of the phase III SigVie-002 study (previously known as Be6A Lung-01).

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

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

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

FDA has granted Hyrnuo (sevabertinib) priority review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations in patients with no prior therapy.

May 22, 2026

Vol.52 No.20

Drugs & Targets

FDA accepts NDA for zipalertinib for NSCLC with mutations

FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.

May 01, 2026

Vol.52 No.17

EC approves Keytruda as adjuvant treatment for NSCLC at high risk of recurrence

YOU MAY BE INTERESTED IN

Sigvotatug vedotin misses OS primary endpoint vs. docetaxel in phase III trial in previously treated metastatic non-squamous NSCLC

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

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

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

FDA accepts NDA for zipalertinib for NSCLC with mutations

Renew today!

Subscriber content

Never miss an issue!

Login