Caroline Seymour

The FDA has granted an orphan drug designation to PYX-201 for the treatment of patients with pancreatic cancer.

Treatment with trastuzumab deruxtecan resulted in lower exposure-adjusted incidence rates per patient-year of treatment-emergent adverse effects compared with treatment of physician’s choice in patients with HER2-low unresectable and/or metastatic breast cancer, according to safety analysis from the phase 3 DESTINY-Breast04 trial.

Mirvetuximab soravtansine-gynx led to a clinically meaningful and statistically significant improvement in progression-free survival, overall survival, and objective response rate vs single-agent chemotherapy in patients with platinum-resistant ovarian cancer whose tumors express high levels of folate receptor alpha, according to topline findings from the phase 3 MIRASOL trial.

Iptacopan elicited improved hemoglobin levels measuring at least 2 g/dL higher vs baseline, leading to transfusion independence after 24 weeks in approximately 92.2% of patients with complement inhibitor–naïve paroxysmal nocturnal hemoglobinuria.

The European Medicines Agency has validated a type II variation for potential approval of dostarlimab in combination with carboplatin and paclitaxel for the treatment of patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

Leaked data from an abstract scheduled to be presented at the 2023 EHA Hybrid Congress showed that ciltacabtagene autoleucel demonstrated a 74% reduction in the risk of disease progression or death compared with standard therapy in patients with relapsed/refractory multiple myeloma who received 1 to 3 prior lines of therapy.

The combination of PARP and ATR inhibition with olaparib and ceralasertib was tolerable but showed limited efficacy in pediatric patients with advanced malignancies harboring DNA replication stress and DNA repair deficiencies, according to findings from arm N of the phase 1/2 AcSé-ESMART trial.

The BCMA- and CD3-directed bispecific antibody REGN5459 led to fast onset, deep, and dose-dependent responses sustained over time, with a high frequency of manageable low-grade cytokine release syndrome in patients with relapsed/refractory multiple myeloma.

Perioperative durvalumab plus neoadjuvant platinum-based chemotherapy demonstrated a statistically significant improvement in pathologic complete response and event-free survival vs placebo plus chemotherapy in patients with resectable non–small cell lung cancer.

The FDA has granted an orphan drug designation to TP-1287, an investigational oral CDK9 inhibitor, for the treatment of patients with Ewing sarcoma.

The FDA has accepted for review a supplemental biologics license application for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

The Scottish Medicines Consortium has accepted fam-trastuzumab deruxtecan-nxki as a treatment option for adult patients with HER2-positive unresectable or metastatic breast cancer who have received 1 prior anti–HER2-based therapy.

The FDA has granted an orphan drug designation to osemitamab for the treatment of patients with pancreatic cancer, marking the second ODD for the agent following its initial designation in 2021 for use in those with gastric and gastroesophageal junction cancer.

The FDA has granted a fast track designation to SynKIR-110 for the treatment of patients with mesothelioma.

The FDA has accepted a biologics license application for the HLX02, a proposed trastuzumab biosimilar, as adjuvant therapy for patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma

The FDA has accepted for review supplemental new drug applications for the combination of encorafenib and binimetinib for the treatment of patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.

Treatment with rusfertide led to a higher response rate of 69.2% vs 18.5% with placebo in patients with polycythemia vera, meeting the primary end point of the phase 2 REVIVE trial.

The use of 4 cycles of chemotherapy plus durvalumab with or without tremelimumab-actl was associated with improved or sustained response and similar toxicity compared with chemotherapy alone as frontline therapy in patients with metastatic non–small cell lung cancer, according to post hoc exploratory findings from the phase 3 POSEIDON trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of select patients with large B-cell lymphoma who relapsed within 12 months from completion of or developed refractory disease to frontline chemoimmunotherapy.

Neoadjuvant nivolumab plus chemotherapy produced a long-term event-free survival benefit vs chemotherapy alone in patients with resectable non–small cell lung cancer, independent of whether patients underwent minimally invasive surgery or thoracotomy or complete or partial resection of the lung.

The European Commission has approved cemiplimab-rwlc plus platinum-based chemotherapy for the frontline treatment of patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer without EGFR, ALK, or ROS1 alterations and who are not eligible for chemoradiation.

Neoadjuvant treatment with olaparib prior to surgical resection and adjuvant chemotherapy was well tolerated and led to a 100% optimal resection rate in patients with newly diagnosed, BRCA-mutant ovarian, primary peritoneal, or fallopian tube cancer.

Treatment with the oral, small-molecule Wee1 kinase inhibitor adavosertib was clinically active but not well tolerated in patients with recurrent or persistent uterine serous carcinoma who previously received platinum-based chemotherapy.

The FDA has issued a complete response letter for ruxolitinib extended-release tablets for use once daily in the treatment of patients with certain types of myelofibrosis, polycythemia vera, and graft-vs-host disease.

Acalabrutinib has received conditional approval from the National Medical Products Administration in China for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

The addition of MEDI9253 to sequential or concurrent treatment with durvalumab failed to elicit more than 1 partial response although proving feasible and safe in patients with advanced or metastatic solid tumors, according to findings from a phase 1 trial.

The FDA has granted an orphan drug designation to ISB 1442, the first-in-class biparatopic 2+1 BEAT® bispecific antibody targeting CD38 and CD47 for the treatment of patients with relapsed/refractory multiple myeloma.

The phase 1/2 trial evaluating the addition of Allocetra to standard chemotherapy administered via pressurized intraperitoneal aerosol chemotherapy received regulatory clearance to continue evaluation and launch the dose-escalation cohort in patients with advanced-stage peritoneal metastasis arising from solid tumors following the completion of an interim data review by an Independent Data and Safety Monitoring Board and the Israeli Ministry of Health.

Enzalutamide plus leuprolide demonstrated a statistically significant and clinically meaningful improvement in metastasis-free survival compared with placebo plus leuprolide in patients with nonmetastatic castration-sensitive prostate cancer with a high-risk of biochemical recurrence.