Kristi Rosa

The European Commission has approved the tablet formulation of acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia.

Treatment with cabozantinib elicited responses in patients with locally advanced or metastatic renal cell carcinoma with a clear-cell component who had progressed after first-line treatment with checkpoint inhibitor–based combination therapy.

Orca-Q when using myeloablative conditioning with only tacrolimus monotherapy in the haploidentical stem cell transplant setting had acceptable safety and resulted in encouraging outcomes for patients with high-risk hematologic malignancies.

The addition of pembrolizumab to chemotherapy resulted in a significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate vs chemotherapy alone when used as first-line treatment in patients with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma.

The fully-human scFv CD19-targeted CAR T-cell therapy JCAR021 elicited durable responses but with a high rate of neurotoxicity when administered at a dose of 7 x 106 cells/kg in patients with relapsed or refractory large B-cell lymphoma, according to data from a phase 1/2 trial.

The combination of maveropepimut-S, pembrolizumab, and intermittent low-dose cyclophosphamide elicited responses in patients with relapsed or refractory diffuse large B-cell lymphoma, according to preliminary findings from the phase 2b VITALIZE trial.

The FDA has granted a regular approval to dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient, recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.

Neoadjuvant pembrolizumab was found to have high clinical activity and an acceptable safety profile in patients with localized microsatellite instability–high/deficient mismatch repair solid tumors.

The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a BTK inhibitor.

The addition of nab-paclitaxel to gemcitabine and cisplatin did not result in a statistically significant improvement in overall survival over gemcitabine/cisplatin alone in patients with newly diagnosed, advanced biliary tract cancers.

The combination of nivolumab (Opdivo) and chemotherapy continued to provide a clinically meaningful long-term survival benefit and deeper responses than chemotherapy alone in previously untreated patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, according to 3-year follow-up data from the phase 3 CheckMate-649 trial.

The National Medical Products Administration of China has approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations and whose disease progressed on or following platinum-based chemotherapy.

The FDA has granted a fast track designation to BT8009 for use as a monotherapy in adult patients with previously treated locally advanced or metastatic urothelial cancer.

Ripretinib improved progression-free survival, objective response rate, and overall survival over sunitinib when given as second-line treatment to patients with gastrointestinal stromal tumor harboring mutations in KIT exon 11 and 17/18 only and who received prior imatinib.

Significant and durable transfusion independence was achieved with imetelstat vs placebo in patients with lower-risk myelodysplastic syndromes who were relapsed, refractory, or ineligible for erythropoiesis-stimulating agents, meeting the primary and a key secondary end point of the phase 3 IMerge trial.

The FDA has approved mosunetuzumab-axgb (Lunsumio) for the treatment of adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

Obecabtagene autoleucel elicited an overall remission rate of 70% in 50 efficacy-evaluable adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, meeting the primary end point of the phase 2 FELIX trial.

The FDA has approved nadofaragene firadenovec-vncg (Adstiladrin) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

The addition of zolbetuximab to capecitabine and oxaliplatin resulted in a statistically significant improvement in progression-free survival and overall survival vs placebo/CAPOX in patients with Claudin 18.2–positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal cancers, meeting the primary and secondary end points of the phase 3 GLOW trial.

The FDA has approved updated labeling for capecitabine tablets (Xeloda) under an initiative aimed to ensure labeling information is clinically meaningful and scientifically up to date.

Galera Therapeutics, Inc. has submitted a new drug application to the FDA that is seeking the approval ofavasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer who are undergoing standard treatment.

Ziftomenib monotherapy had a manageable toxicity profile and provided pronounced antileukemic activity when given at a 600-mg dose in heavily pretreated patients with relapsed or refractory acute myeloid leukemia.

Watchful waiting followed by sequential conditioning prior to allogeneic hematopoietic cell transplantation provided similar overall survival and leukemia-free survival to that achieved with intensive remission induction chemotherapy comprised of high-dose cytarabine and mitoxantrone followed by allogeneic hematopoietic cell transplantation in patients with relapsed or refractory acute myeloid leukemia.

The FDA has approved atezolizumab (Tecentriq) for adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.

Lifileucel achieved safety and efficacy irrespective of the number of aldesleukin doses administered to patients with advanced melanoma.

Concurrent adagrasib and pembrolizumab produced preliminary activity when administered as first-line treatment in patients with non–small cell lung cancer harboring a KRAS G12C mutation, irrespective of PD-L1 status, according to data from the KRYSTAL-1 phase 1b and the KRYSTAL-7 phase 2 cohorts.

The combination of the p38 MAPK inhibitor ARRY-614 plus nivolumab with or without ipilimumab was well tolerated and elicited disease control in high-risk, PD-(L)1–refractory patients with advanced solid tumors.

The FDA has approved a supplemental biologics license application to add a Monday/Wednesday/Friday intramuscular dosing schedule for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze).

Ponatinib plus reduced-intensity chemotherapy produced a higher rate of minimal residual disease–negative complete remission compared with imatinib in patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

Onatasertib plus toripalimab elicited an objective response rate of 52.4% in patients with relapsed or metastatic cervical cancer, irrespective of PD-L1 expression.