Kristi Rosa

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of nivolumab and ipilimumab as an option for patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following fluoropyrimidine-based combination therapy.

A biologics license application has been submitted to the FDA for the PD-1 monoclonal antibody penpulimab for the third-line treatment of patients with metastatic nasopharyngeal carcinoma.

The FDA has announced that it will need more time to review the biologics license application for narsoplimab as a potential therapeutic option in patients with hematopoietic stem cell transplant–associated thrombotic microangiopathy.

The FDA has accepted a new drug application for maribavir for the treatment of post-transplant recipients with cytomegalovirus infection who are refractory and/or resistant to previous anti-CMV treatment.

The FDA has approved amivantamab-vmjw as the first treatment for adult patients with non–small cell lung cancer who harbor EGFR exon 20 insertion mutations.

The combination of the anti–PD-1 tislelizumab and chemotherapy was found to significantly improve progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial.

The FDA has approved nivolumab for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, in patients have received neoadjuvant chemoradiotherapy.

The biologics license application seeking the approval of ropeginterferon alfa-2b-njft for use in the treatment of patients with polycythemia vera has been resubmitted to the FDA.

The FDA has granted a fast track designation to the CAR T-cell product AIC100 for the treatment of patients with anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer.

The FDA has granted priority review to a supplemental new drug application for zanubrutinib as a treatment option for adult patients with marginal zone lymphoma who have previously received at least 1 anti-CD20–based therapy.

Loncastuximab tesirine-lypl has demonstrated significant antitumor activity with durable responses and an acceptable toxicity profile, when used as a monotherapy in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma.

A biologics license application for sintilimab injection plus pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with nonsquamous non–small cell lung cancer has been accepted for FDA review.

The FDA has lifted a partial clinical hold that had been placed on the enrollment of patients with follicular lymphoma and diffuse large B-cell lymphoma to monotherapy trials examining the bispecific antibody odronextamab.

Enobosarm has been shown to induce a clinical benefit rate of 50% at 24 weeks in evaluable patients with measurable metastatic androgren receptor–positive, estrogen receptor–positive, metastatic breast cancer that has progressed on treatment with palbociclib.

The FDA has approved pegcetacoplan (Empaveli) for the treatment of adults with paroxysmal nocturnal hemoglobinuria who are treatment naïve and those who are switching from the C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris).

An off-the-shelf, allogeneic CD30-CAR Epstein Barr virus–specific T-cell therapy has demonstrated favorable safety and encouraging clinical activity, even when given at lower dose levels, in patients with relapsed/refractory CD30-positive lymphoma.

The PD-1 inhibitor cemiplimab resulted in a 31% reduction in the risk of death compared with chemotherapy in patients with recurrent or metastatic cervical cancer who have progressed on chemotherapy.

Neoadjuvant pembrolizumab in combination with chemotherapy followed by adjuvant pembrolizumab monotherapy resulted in a significant improvement in event-free survival and pathologic complete response vs neoadjuvant chemotherapy alone in patients with high-risk, early-stage triple-negative breast cancer.

The FDA has granted a breakthrough device designation to the Avenda Health Focal Therapy System, a male “lumpectomy” product under development to treat patients with prostate cancer in office while preserving quality of life.

The quadruplet combination comprised of carfilzomib, lenalidomide, dexamethasone, and daratumumab was linked with high rates of minimal residual disease negativity and progression-free survival in patients with newly diagnosed multiple myeloma.

The FDA has granted an orphan drug designation to the first-in-class ruthenium-based small molecule therapeutic BOLD-100 for the treatment of patients with gastric cancer.

Although fewer deaths were reported with neratinib in patients with HER2-positive breast cancer treated on the phase 3 ExteNET trial, the agent was not found to result in a significant improvement in overall survival after 8 years of follow-up.

Stratification by the molecular 70-gene risk prediction signature revealed that patients with estrogen receptor–positive breast cancer who are low risk for disease recurrence derive greater benefit from tamoxifen, while those who are high risk have greater benefit from goserelin vs no endocrine therapy.

Distinct gene signatures, with the exception of estrogen receptor signaling and BRCAness, are associated with pathologic complete response and invasive disease-free survival, in patients with HER2-positive breast cancer who received trastuzumab and pertuzumab alone or in combination with paclitaxel.

Approximately 30% of breast cancer tumors can covert from, or to, HER2-low status, underscoring the need to retest for HER2 expression upon relapse.

The combination of durvalumab plus tremelimumab and platinum-based chemotherapy resulted in a significant improvement in overall survival compared with chemotherapy alone in the frontline treatment of patients with stage IV non–small cell lung cancer.

The recently FDA-approved loncastuximab tesirine-lpyl has been added to the latest National Comprehensive Cancer Network Clinical Practice Guidelines for B-cell lymphomas.

The FDA has granted priority review to applications that are seeking 2 approvals of pembrolizumab in combination with lenvatinib in advanced renal cell carcinoma and advanced endometrial carcinoma.

The FDA has approved pembrolizumab for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma.

The European Commission has approved atezolizumab for use as a frontline treatment in patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and do not harbor EGFR or ALK aberrations.