Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: [email protected]
The FDA has granted a fast track designation to KIN-2787 for use as a potential therapeutic option in patients with BRAF class II or III alteration–positive and/or NRAS mutation–positive, metastatic or unresectable, stage IIB to IV malignant melanoma.
The FDA has granted accelerated approval to selpercatinib for adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion that have progressed on or after previous systemic treatment or who have no satisfactory alternative treatment options.
The FDA has granted a regular approval to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic non–small cell lung cancer harboring a RET gene fusion, as detected by an FDA-approved test.
Zanidatamab zovodotin was found to produce encouraging responses and to have a manageable toxicity profile when used as a monotherapy in heavily pretreated patients with HER2-positive solid cancers.
The FDA has approved sodium thiosulfate (Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, nonmetastatic solid tumors.
The China National Medical Products Administration has approved the supplemental new drug application seeking the approval of toripalimab plus pemetrexed and platinum as a frontline treatment in unresectable, locally advanced or metastatic, nonsquamous non–small cell lung cancer not harboring EGFR mutations or ALK fusions.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib for use in adult patients with marginal zone lymphoma who have received at least 1 prior anti–CD20-based therapy.
The FDA has granted a priority review to a supplemental new drug application seeking the approval of tucatinib for use in combination with trastuzumab in adult patients with HER2-positive colorectal cancer who have received at least 1 prior treatment regimen for unresectable or metastatic disease.
The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab for use in the frontline treatment of select patients with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.
The FDA has granted an orphan drug designation to the CDK7 inhibitor SY-5609 for use as a potential therapeutic option in patients with relapsed metastatic pancreatic cancer.
Maintenance treatment with niraparib produced a sustained and durable progression-free survival benefit in patients with primary advanced ovarian cancer who responded to first-line platinum-based chemotherapy, spanning biomarker subgroups.
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.
