Kristi Rosa

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.

The addition of zolbetuximab to oxaliplatin, leucovorin, and fluorouracil significantly improved progression-free survival vs fluorouracil alone in patients with Claudin 18.2–positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

The addition of eganelisib to atezolizumab and nab-paclitaxel demonstrated evidence of a long-term progression-free survival benefit when used as first-line treatment in patients with metastatic triple-negative breast cancer according to updated data from the phase 2 MARIO-3 trial.

The addition of fruquintinib to paclitaxel in the second-line treatment of Chinese patients with advanced gastric or gastroesophageal junction adenocarcinoma significantly improved progression-free survival over paclitaxel alone.

The FDA has granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for the treatment of select patients with folate receptor α–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib in combination with abiraterone acetate and prednisone or prednisolone for use in adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not indicated.

At the request of the FDA, GlaxoSmithKline plc will restrict the second-line maintenance indication for niraparib to only the population of patients with recurrent ovarian cancer whose tumors harbor deleterious or suspected deleterious germline BRCA mutations.

All patients with prostate cancer, except for those with low-risk or very low-risk localized disease, should be tested for germline mutations, and somatic testing should be done in all patients with metastatic disease as there are therapeutic implications.

For patients with metastatic castration-resistant prostate cancer who experience disease progression on novel hormonal agents (NHAs) and androgen deprivation therapy, it is important to consider when the NHA was received and whether docetaxel has been administered, as these factors affect downstream options and sequencing.

Because androgen deprivation therapy alone or with docetaxel is not recommended for most patients with metastatic castration-sensitive prostate cancer, a decision must be made between leveraging couplets vs triplets.

The FDA has approved tremelimumab-actl (Imjudo) plus durvalumab (Imfinzi) and platinum-based chemotherapy for adult patients with metastatic non–small cell lung cancer without sensitizing EGFR mutation or ALK aberrations.

The FDA has approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide in pediatric patients aged 2 years and older with previously untreated, high-risk classical Hodgkin lymphoma.

Milademetan monotherapy demonstrated preliminary antitumor activity in patients with MDM2-amplified and p53 wild-type advanced solid tumors.