Global Oncology

The European marketing authorization application of infigratinib for the treatment of advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements has been withdrawn by Helsinn Birex Pharmaceuticals.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has approved darolutamide tablets in combination with androgen deprivation therapy and docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.

The United Kingdom’s National Institute for Health and Care Excellence has issued final guidance recommending the use of nivolumab plus chemotherapy as a treatment option for patients with HER2-negative advanced stomach and esophageal cancer.

The European Commission has approved cemiplimab-rwlc monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer who have progressed on or after platinum-based chemotherapy.

The European Commission has approved zanubrutinib for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia.

The United Kingdom’s National Institute for Health and Care Excellence has issued final guidance recommending the use of mobocertinib for patients with advanced non–small cell lung cancer harboring EGFR exon 20 insertion mutations who have already received platinum-based chemotherapy.

The Center for Drug Evaluation of the China National Medical Products Administration has granted a breakthrough therapy designation to ivonescimab plus docetaxel for patients with locally advanced or metastatic non–small cell lung cancer who failed to respond to a prior PD-(L)1 inhibitor plus platinum-based doublet chemotherapy.

The addition of fruquintinib to paclitaxel in the second-line treatment of Chinese patients with advanced gastric or gastroesophageal junction adenocarcinoma significantly improved progression-free survival over paclitaxel alone.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib in combination with abiraterone acetate and prednisone or prednisolone for use in adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not indicated.

Ibrutinib induced a cumulative overall response rate of 90.0% in 3-year findings from the Belgian Ibrutinib Real‑World Data study of patients with previously untreated or relapsed/refractory chronic lymphocytic leukemia.

The China National Medical Products Administration has granted a breakthrough therapy designation to ivonescimab for use in combination with chemotherapy in patients with EGFR-mutated advanced non–small cell lung cancer in whom prior treatment with an EGFR TKI has failed.

The European Commission has approved axicabtagene ciloleucel for the treatment of adult patients with diffuse large B-cell lymphoma or high-grade B-cell lymphoma who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Lutetium 177 vipivotide tetraxetan in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition for the treatment of adult patients with progressive prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for cemiplimab monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after platinum-based chemotherapy.

The Japan Ministry of Health, Labor and Welfare has approved valemetostat tosilate for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma.

Olaparib plus bevacizumab was approved in China as a first-line maintenance treatment for homologous recombination deficiency–positive ovarian cancer following a response to platinum-based chemotherapy plus bevacizumab.

The China National Medical Products Administration has approved the supplemental new drug application seeking the approval of toripalimab plus pemetrexed and platinum as a frontline treatment in unresectable, locally advanced or metastatic, nonsquamous non–small cell lung cancer not harboring EGFR mutations or ALK fusions.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib for use in adult patients with marginal zone lymphoma who have received at least 1 prior anti–CD20-based therapy.

The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab for use in the frontline treatment of select patients with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.

Tislelizumab continued to demonstrate an improved clinical benefit compared with docetaxel in both Asian and non-Asian patients with previously treated advanced non–small cell lung cancer.

The European Commission has granted an orphan drug designation to nanatinostat and valganciclovir for use as a potential therapeutic option in patients with peripheral T-cell lymphoma.

The Hong Kong Special Administrative Region’s Department of Health has accepted for review a biologics license application seeking the approval of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.

Daiichi Sankyo submitted a supplemental new drug application to Japan’s Ministry of Health, Labor, and Welfare for the use of quizartinib in patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

The European Commission has approved asciminib for the treatment of patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who received prior treatment with at least 2 TKIs

The Japanese Ministry of Health, Labour, and Welfare has approved osimertinib for use as an adjuvant treatment in patients with EGFR-mutated non–small cell lung cancer.

The European Commission has approved the fixed-duration, all-oral combination of ibrutinib and venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia.

The European Commission has granted conditional marketing authorization to teclistamab for use as a single agent in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

CE label expansion was granted to the Ventana PD-L1 assay for use as a companion diagnostic to identify patients with non–small cell lung cancer who are eligible for treatment with adjuvant atezolizumab.

The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The European Medicines Agency has accepted the marketing authorization application for the oral fixed-dose combination of decitabine and cedazuridine for the frontline treatment of adults with acute myeloid leukemia who are not candidates for standard induction chemotherapy.