Kristi Rosa

The FDA has granted a regular approval to dostarlimab-gxly (Jemperli; GSK) 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.

Trastuzumab deruxtecan resulted in a statistically significant improvement in progression-free survival and overall survival compared with physician’s choice of chemotherapy in patients with HER2-low unresectable and/or metastatic breast cancer, irrespective of hormone receptor status, meeting the primary and secondary end points of the phase 3 DESTINY-Breast 04 trial.

Frontline maintenance treatment with selinexor resulted in a statistically significant improvement in median progression-free survival vs placebo in patients with advanced or recurrent endometrial cancer, meeting the primary end point of the phase 3 SIENDO trial.

The clinical-stage immunotherapy company PDS Biotechnology Corporation has announced the temporary suspension of recruitment to the National Cancer Institute–led phase 2 trial, which is evaluating a novel triplet combination comprised of PDS0101 and 2 immunomodulating agents in patients with advanced human papillomavirus cancers.

The FDA has granted a fast track designation to the interleukin-2 variant immunotherapy nemvaleukin alfa for use in combination with pembrolizumab in the treatment of patients with platinum-resistant ovarian cancer.

The immuno-oncology company Agenus has made the decision to withdraw its biologic license application for the use of the PD-1 inhibitor balstilimab in patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.

The FDA has approved the Ki-67 IHC MIB-1 pharmDx test to assist in determining which patients with early breast cancer who are at high risk of disease recurrence might benefit from adjuvant treatment with abemaciclib plus endocrine therapy.

The FDA has approved abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of 20% or higher, as determined by an FDA-approved test.

The FDA has granted priority review to a supplemental biologics license application for the use of cemiplimab-rwlc in the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on, or after, chemotherapy.