Chris Ryan

As additional antibody-drug conjugates continue to emerge for the treatment of patients with HER2-negative breast cancer, identifying optimal sequencing strategies and managing toxicities associated with these agents remain top priorities for their use, according to Hope S. Rugo, MD.

A new drug application has been submitted to the FDA seeking the approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet, and prednisone, for the first-line treatment of patients with metastatic castration-resistant prostate cancer harboring BRCA mutations.

The FDA has accepted a supplemental biologics license application for neoadjuvant pembrolizumab in combination with platinum-containing chemotherapy, followed by adjuvant pembrolizumab monotherapy, for the treatment of patients with resectable stage II, IIIA, or IIIB (T3-4N2) non–small cell lung cancer.

Enrollment has commenced for a phase 2 trial investigating the DNA-based interleukin-12 immunotherapy IMNN-001 in combination with bevacizumab and chemotherapy in patients with advanced ovarian cancer.

The FDA has accepted the supplemental biologics license application for nivolumab as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma.

The FDA has granted a priority review to the new drug application for nirogacestat for the treatment of adult patients with desmoid tumors.

The FDA has granted a breakthrough therapy designation to the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with pembrolizumab for the adjuvant treatment of patients with high-risk melanoma following complete resection.

The FDA has granted a priority review to the biologics license application for elranatamab for the treatment of patients with relapsed/refractory multiple myeloma.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted full marketing authorization for selinexor in combination with bortezomib and low-dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.

Talazoparib plus enzalutamide generated a statistically significant and clinically meaningful improvement in radiographic progression-free survival vs placebo plus enzalutamide as first-line treatment for patients with metastatic castration-resistant prostate cancer, irrespective of homologous recombination repair status.

ADI-001, a first-in-class, allogeneic gamma delta1 CAR T-cell therapy, elicited responses and demonstrated a favorable safety profile in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

The FDA has granted priority review to the new drug application for avasopasem manganese as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.

The FDA has granted regenerative medicine advanced therapy and fast track designations to equecabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma.

Adding trilaciclib to FOLFOXIRI and bevacizumab led to statistically significant reductions in instances of severe neutropenia during induction and duration of severe neutropenia in cycles 1 to 4. However, the combination failed to improve antitumor activity vs placebo plus FOLFOXIRI/bevacizumab in patients with metastatic colorectal cancer.

Idecabtagene vicleucel improved progression-free survival compared with standard combination regimens in patients with relapsed/refractory multiple myeloma after 2 to 4 prior lines of therapy and who were refractory to their last regimen, according to results from the phase 3 KarMMa-3 trial.

Elevation Oncology is pausing development of the human anti–HER3 IgG2 monoclonal antibody seribantumab, along with the phase 2 CRESTONE trial investigating the agent, in patients with advanced solid tumors harboring NRG1 fusions.

The CAR T-cell therapy brexucabtagene autoleucel produced a median overall survival of 26 months in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

FDA approvals in recent years have started to carve out a role for immunotherapy in the frontline treatment of patients with small cell lung cancer.

The World Health Organization has released new framework guidelines with the goal of saving 2.5 million lives from breast cancer by 2040 through a combination of early detection, timely diagnosis, and comprehensive management.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.

The combination of pembrolizumab plus carboplatin and paclitaxel demonstrated a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in the first-line treatment of patients with stage III/IV or recurrent endometrial cancer.

The FDA has granted orphan drug exclusivity to sodium thiosulfate injection, which is indicated to reduce the risk of platinum-induced ototoxicity in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.

Ciltacabtagene autoleucel demonstrated a significant improvement in progression-free survival in patients with relapsed/lenalidomide-refractory multiple myeloma who received 1 to 3 prior lines of therapy.

Magenta Therapeutics has voluntarily paused enrollment for a phase 1/2 trial evaluating the antibody-drug conjugate MGTA-117 in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome following the death of a patient.

The CAR T-cell therapy lisocabtagene maraleucel induced complete responses in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic leukemia.

The combination of avutometinib and defactinib elicited responses in patients with recurrent low-grade serous ovarian cancer, according to data from a planned interim analysis of the registration-directed phase 2 RAMP-201 trial.

Merck is discontinuing the phase 3 KEYNOTE-991 trial evaluating pembrolizumab plus enzalutamide and androgen deprivation therapy vs placebo plus enzalutamide/ADT in patients with metastatic hormone-sensitive prostate cancer due to futility.

Bavituximab in combination with pembrolizumab produced responses in patients with previously untreated advanced hepatocellular carcinoma.

Second-line ripretinib produced a clinical benefit in patients with advanced gastrointestinal stromal tumor harboring KIT exon 11 and 17/18 mutations who progressed on or were intolerant to imatinib.