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FDA Approves Pembrolizumab With Chemotherapy in Advanced Endometrial Carcinoma

Durvalumab Plus Chemotherapy Receives Approval for dMMR Primary Advanced or Recurrent Endometrial Cancer
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The latest approval of lisocabtagene maraleucel (liso-cel) in mantle cell lymphoma provides another treatment option and continues the tremendous advances in treatment for patients, said Christopher Flowers, MD, of MD Anderson Cancer Center.

Mantle cell lymphoma is the fourth subtype of non-Hodgkin lymphoma that can be treated with this CAR T-cell therapy.


The FDA has approved tarlatamab (Imdelltra; Amgen), a novel bispecific T-cell engager, to treat patients with extensive-stage small cell lung cancer (SCLC).

This interim analysis of the CheckMate 77T trial, outcomes were compared between adult patients receiving neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo for resectable non–small cell lung cancer (NSCLC).

FDA has given accelerated approval for lisocabtagene maraleucel (liso-cel; Breyanzi) for patients with relapsed or refractory (R/R) follicular lymphoma.

Pembrolizumab has existing indications in endometrial cancer.

FDA Accepts Nivolumab Subcutaneous Injection Application, With Potential to Boost Access to PD-1 Inhibitors
Some experts believe offering a subcutaneous version of nivolumab could make PD-1 inhibitors available to new groups of patients who currently lack access, such as those in rural areas.

Authors discuss the merits of using a pair of immunotherapy treatments aimed at separate targets.

"Off the shelf" CAR T-cell therapies could offer a solution in chronic lymphocytic leukemia, where T-cell exhaustion creates treatment challenges.

The principal investigator of the study leading to approval said this new immunotherapy could be a "game changer" in bladder cancer.

A tumor board looked to studies in ovarian cancer for guidance on use of immunotherapy in a rare case of clear cell carcinoma of the cervix.

Government agencies have created an online portal for the public to report potential anticompetitive practices in health care; there are changes coming to the “boxed warning” section for chimeric antigen receptor T-cell therapies (CAR T) to highlight T-cell blood cancer risk; questions about the safety of obesity medications during pregnancy have arisen in women on them who previously struggled with fertility issues.

Results show the bispecific antibody is effective in an earlier line of treatment.


The authors say a standard method of assessing metabolic tumor volume would be needed for its use to become widespread.


An alternative dose of ipilimumab and nivolumab had less toxicity than a conventional dose, the results show.

Results are consistent with the authors' prior findings on the possible effects of circadian rhythm on outcomes after immunotherapy.

The Princess of Wales is likely referencing adjuvant chemotherapy, but there is a growing field of immunoprevention, which seeks to target precancerous lesions or block heritable cancers.

This is the second time the combination has failed to meet end points in a trial in non–small cell lung cancer (NSCLC).

The approval fills a void for patients with CLL or SLL whose disease progresses after treatment with a BTK inhibitor and a BCL-2 inhibitor; until now, there has been no standard of care.

Results come amid the FDA's review of chimeric antigen receptor (CAR) T-cell therapy.

A real-world study confirmed that the rate of adverse events associated with first-line nivolumab plus iplimumab therapy was in line with the safety profiles of other immuno-oncology and chemotherapy combination regimens.











