Global

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has accepted a marketing authorization application seeking approval for sugemalimab plus chemotherapy as first-line treatment for patients with metastatic non–small cell lung cancer.

The European Commission has approved fam-trastuzumab deruxtecan-nxki as monotherapy for the treatment of patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval for the use of trastuzumab deruxtecan monotherapy for adults with unresectable or metastatic HER2-low breast cancer.

Daiichi Sankyo has filed a supplemental new drug application with Japan’s Ministry of Health, Labor, and Welfare for the use of fam-trastuzumab deruxtecan-nxki in adults with previously treated HER2-mutant unresectable advanced or recurrent non–small cell lung cancer.

The European Commission has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.

Long-term clinical data failed to show a benefit of neoadjuvant olaparib (Lynparza) plus paclitaxel vs carboplatin plus paclitaxel in patients with HER2-negative early breast cancer with homologous recombination deficiency.

Neoadjuvant treatment with nivolumab (Opdivo) plus platinum doublet chemotherapy showed superior major pathological response rates and pathological complete response rates compared with nivolumab monotherapy among patients with resectable non–small cell lung cancer even for patients with a PD-L1 expression of 50% or greater.

Using circulating tumor cell count as a guide to first-line treatment, either with chemotherapy or endocrine therapy, resulted in an improvement in overall survival compared with physician’s choice of treatment without CTC count for patients with metastatic, hormone receptor–positive/HER2-negative breast cancer.

The development of zandelisib for the treatment of B-cell malignancies has been discontinued outside of Japan.

The European Medicines Agency has accepted a marketing authorization application for momelotinib as a treatment for patients with myelofibrosis.

Pharmaceutical manufacturer EQRx announced December 2, 2022, that the European Medicines Agency has accepted a marketing authorization application for the use of aumolertinib in EGFR-mutated non–small cell lung cancer and locally advanced or metastatic EGFR T790M mutation–positive NSCLC.

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.