Kristi Rosa

Lasofoxifene plus abemaciclib produced promising efficacy when administered to pre- and postmenopausal patients with locally advanced or metastatic, estrogen receptor–positive, HER2-negative breast cancer who harbored an ESR1 mutation.

A supplemental new drug application and a Type II variation has been submitted to the FDA and the European Medicines Agency, respectively, seeking the approval of rucaparib as frontline maintenance treatment in women with advanced ovarian cancer irrespective of biomarker status who have responded to first-line platinum-based chemotherapy.

The addition of bevacizumab to trifluridine/tipiracil resulted in a statistically significant improvement in overall survival over trifluridine/tipiracil alone in patients with refractory metastatic colorectal cancer after 2 chemotherapy regimens.

The combination of lenvatinib and pembrolizumab was found to induce high response rates, including long-lasting remissions, and have acceptable safety in patients with metastasized anaplastic thyroid carcinoma and poorly differentiated thyroid carcinoma.

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.

Adjuvant osimertinib resulted in a 77% reduction in the risk of disease recurrence or death in patients with EGFR-mutated, stage II to IIIA non–small cell lung cancer, with a disease-free survival improvement observed irrespective of prior adjuvant chemotherapy or disease stage.

The combination of olaparib plus abiraterone acetate and prednisone or prednisolone demonstrated a continuing trend toward an overall survival benefit when used in the first-line treatment of patients with metastatic castration-resistant prostate cancer.

Amcenestrant did not significantly improve progression-free survival over physician’s choice of endocrine monotherapy in patients with endocrine-resistant, estrogen receptor–positive, HER2-negative advanced breast cancer, but it did provide a benefit that was numerically comparable, according to data from the phase 2 AMEERA-3 trial.

Pembrolizumab monotherapy and in combination with anlotinib demonstrated encouraging efficacy and safety when administered to patients with refractory or platinum-resistant recurrent high-grade serous ovarian 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 FDA has granted an orphan drug designation to AVA6000, a modified form of doxorubicin, for the treatment of patients with soft tissue sarcoma.

The FDA has granted an orphan drug designation to WP1122 as a potential therapeutic option for patients with glioblastoma multiforme.

Toripalimab and concurrent chemoradiation elicited encouraging activity with acceptable tolerability in patients with locally advanced cervical cancer.

The addition of the pre- and co-administration of nivolumab with concurrent chemoradiation appeared to be safe and feasible in patients with locally advanced cervical carcinoma, according to data from the phase 1 GOTIC-018 trial.

Data from a recent analysis revealed that nearly 1 in 7 patients with hepatocellular carcinoma experience treatment delays, with higher odds observed in Black patients and those living in high poverty neighborhoods.

The sequential treatment of regorafenib followed by nivolumab was found to have an acceptable toxicity profile in patients with hepatocellular carcinoma who progressed on and tolerated first-line sorafenib, according to early data from the phase 1/2a GOING trial.

The FDA has approved durvalumab (Imfinzi) in combination with gemcitabine and cisplatin in adult patients with locally advanced or metastatic biliary tract cancers.

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.

The combination of plinabulin and pegfilgrastim was well tolerated patients with multiple myeloma who have undergone autologous hematopoietic stem cell transplantation and who have received a high dose of melphalan.

Ciltacabtagene autoleucel elicited encouraging responses in patients with multiple myeloma who had received 1 to 3 prior lines of therapy and were refractory to lenalidomide.

The addition of daratumumab to lenalidomide, bortezomib, and dexamethasone (RVd) induction and consolidation treatment and lenalidomide maintenance therapy (D-RVd/D-R) resulted in high minimal residual disease rates and prolonged progression-free survival in patients with transplant-eligible, newly diagnosed multiple myeloma.

Extended treatment with carfilzomib plus lenalidomide and dexamethasone after autologous stem cell transplant improved progression-free survival over standard lenalidomide maintenance in patients with multiple myeloma.

The FDA has approved pemigatinib (Pemazyre) for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms and FGFR1 rearrangement.

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.

A rolling biologics license application has been submitted to the FDA seeking the approval of lifileucel in patients with advanced melanoma who progressed on or after previous anti–PD-1/PD-L1 therapy, and if BRAF mutation positive, also previous BRAF or BRAF/MEK inhibitor therapy.

The addition of talimogene laherparepvec to pembrolizumab did not significantly improve progression-free survival or overall survival over pembrolizumab alone in patients with advanced melanoma.

The FDA has approved ibrutinib (Imbruvica) for pediatric patients aged 1 year or older with chronic graft versus host disease following failure of 1 or more lines of systemic therapy.

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.

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 FDA has granted a breakthrough therapy designation to taletrectinib for use as a potential therapeutic option in adult patients with advanced or metastatic ROS1-positive non–small cell lung cancer who were ROS1 inhibitor naïve or who previously received crizotinib.