Global

The European Commission has granted marketing authorization for the expanded use of subcutaneous daratumumab for use in 2 new indications.

The European Commission has granted a conditional approval to selumetinib for the treatment of pediatric patients with symptomatic, inoperable plexiform neurofibromas and neurofibromatosis type 1 who are at least 3 years of age.

The China National Medical Products Administration has granted a conditional approval to zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia who have previously received at least 1 therapy.

The National Medical Products Administration of China has approved surufatinib for the treatment of patients with advanced pancreatic neuroendocrine tumors.

The European Commission has granted full marketing authorization to azacitidine tablets for use as a maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission or CR with incomplete blood recovery after induction therapy with or without consolidation treatment, and who are not eligible for, or do not choose to proceed to, hematopoietic stem cell transplant.

The Japan Ministry of Health, Labour, and Welfare has granted conditional and time-limited approval to teserpaturev for the treatment of patients with malignant glioma; this is the first oncolytic virus to receive approval for use in this indication or any primary brain cancer.

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adults with unresectable malignant pleural mesothelioma.

Ivan Marazzi, PhD, discusses the goals for examining topotecan as a treatment for patients with COVID-19 and cancer in India and Brazil.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab for use in 2 advanced cancers: non–small cell lung cancer and basal cell carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2-negative gastroesophageal junction adenocarcinoma with PD-L1 positivity.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of nivolumab and ipilimumab as an option for patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following fluoropyrimidine-based combination therapy.

The combination of the anti–PD-1 tislelizumab and chemotherapy was found to significantly improve progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial.

Ullas Batra, MBBS, MD, DM, discusses the durability of targeted therapy in advanced NSCLC and the movement of targeted therapy and immunotherapy into earlier stages of disease.

Acalabrutinib elicited early antitumor activity with acceptable tolerability in a population of Japanese patients with relapsed/refractory B-cell malignancies.

Kelly de Ligt, PhD, discusses subgroups of symptom burden seen in breast cancer survivors.

Chau T. Dang, MD, discusses the safety profile of pertuzumab plus trastuzumab in patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer.

Effective early detection and optimal management are critical in preventing high-grade interstitial lung disease, a treatment-related adverse effect of fam-trastuzumab deruxtecan-nxki in patients with HER2-positive metastatic breast cancer.

Distinct gene signatures, with the exception of estrogen receptor signaling and BRCAness, are associated with pathologic complete response and invasive disease-free survival, in patients with HER2-positive breast cancer who received trastuzumab and pertuzumab alone or in combination with paclitaxel.

Approximately 30% of breast cancer tumors can covert from, or to, HER2-low status, underscoring the need to retest for HER2 expression upon relapse.

Although administering trastuzumab for 1 year in patients with HER2-positive early breast cancer continues to be standard, a 9-week de-escalation approach may be a reasonable option in a large proportion of the real-world HER2-positive population.

Ribociclib plus endocrine therapy improved overall survival and post-progression outcomes in pre- or postmenopausal patients with hormone receptor–positive, HER2-negative advanced breast cancer irrespective of age.

Treatment with atezolizumab plus carboplatin demonstrated early clinical activity in patients with metastatic invasive lobular breast cancer, with slight trends toward increased clinical benefit in patients with triple-negative ILC and responders with higher PD-L1 expression, according to initial findings of the non-randomized phase 2 GELATO trial.

Post-treatment care for breast cancer survivors must be personalized to address each survivor’s unique experiences.

The European Commission has approved atezolizumab for use as a frontline treatment in patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and do not harbor EGFR or ALK aberrations.

The European Commission has approved enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

Centrally stratified risk-adapted clinical trials in patients with newly diagnosed multiple myeloma were shown to be feasible, addressing an unmet need and providing the opportunity for rapid clinical development of novel therapies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended osimertinib for the adjuvant treatment of adult patients with stage IB, II, or IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.

Current breast cancer screening practices in the Caribbean exclude the majority of the younger patient population, thereby leaving many cases of breast cancer undiagnosed.

The European Medicines Agency has validated a Type II Variation Marketing Authorization Application to Karyopharm Therapeutics Inc. for selinexor in combination with bortezomib and low-dose dexamethasone as a treatment for adult patients with multiple myeloma who have received at least 1 prior therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of nivolumab and ipilimumab as a frontline treatment for adult patients with unresectable malignant pleural mesothelioma.