Kristi Rosa

The FDA has approved pemigatinib (Pemazyre) for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms and FGFR1 rearrangement.

The Japanese Ministry of Health, Labour, and Welfare has approved osimertinib for use as an adjuvant treatment in patients with EGFR-mutated non–small cell lung cancer.

A rolling biologics license application has been submitted to the FDA seeking the approval of lifileucel in patients with advanced melanoma who progressed on or after previous anti–PD-1/PD-L1 therapy, and if BRAF mutation positive, also previous BRAF or BRAF/MEK inhibitor therapy.

The addition of talimogene laherparepvec to pembrolizumab did not significantly improve progression-free survival or overall survival over pembrolizumab alone in patients with advanced melanoma.

The FDA has approved ibrutinib (Imbruvica) for pediatric patients aged 1 year or older with chronic graft versus host disease following failure of 1 or more lines of systemic therapy.

The European Commission has granted conditional marketing authorization to teclistamab for use as a single agent in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The FDA has granted a breakthrough therapy designation to taletrectinib for use as a potential therapeutic option in adult patients with advanced or metastatic ROS1-positive non–small cell lung cancer who were ROS1 inhibitor naïve or who previously received crizotinib.

The European Commission has approved the bevacizumab biosimilar, CT-P16, for the treatment of patients with metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.

The United Kingdom Medicines and Healthcare Products Regulatory Agency has extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.

The combination of lenalidomide and rituximab demonstrated durable safety and efficacy that was comparable to that achieved with rituximab plus chemotherapy in previously untreated patients with follicular lymphoma, according to 6-year data from the phase 3 RELEVANCE trial.

The FDA has approved betibeglogene autotemcel (Zynteglo) for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.

A combination regimen comprised of ruxolitinib and pomalidomide was found to be safe and feasible in a cohort of intermediate-2 and high-risk patients with primary or secondary myelofibrosis and anemia, according to data from the phase 1b/2 MPNSG-0212 trial.

The FDA has granted priority review to a supplemental new drug application seeking the approval of olaparib in combination with abiraterone acetate and prednisone or prednisolone in adult patients with metastatic castration-resistant prostate cancer.

The European Commission has granted an orphan medicinal product designation to INBRX-109 for use as a potential therapeutic option in patients with chondrosarcoma.

The dual immunotherapy combination comprised of nivolumab given at 1 mg/kg and ipilimumab given at 3 mg/kg provided durable responses and long-term survival benefit in patients with advanced hepatocellular carcinoma following treatment with sorafenib.

The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic non–small cell lung cancer whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received previous systemic therapy.

The FDA has granted regular approval to capmatinib (Tabrecta) for adult patients with metastatic non–small cell lung cancer whose tumors have a mutation leading to MET exon 14 skipping, as detected by an FDA-approved test.

The FDA has granted priority review to a new drug application seeking the approval of elacestrant for use in patients with estrogen receptor–positive/HER2-negative advanced or metastatic breast cancer.

Although frontline treatment with avelumab resulted in a longer overall survival and progression-free survival than that observed with platinum-based chemotherapy in patients with advanced non–small cell lung cancer and high PD-L1 positivity, this difference did not achieve statistical significance.

First-line treatment with tislelizumab was found to result in a noninferior overall survival benefit to that achieved with sorafenib in adult patients with unresectable hepatocellular carcinoma, meeting the primary end point of the phase 3 RATIONALE 301 trial.

The combination of talazoparib and temozolomide elicited an objective response rate of 39.3% in patients with extensive-stage small cell lung cancer who were relapsed or refractory to a frontline platinum-based chemotherapy regimen, according to data from a phase 2 UCLA/TRIO-US L-07 trial.

The addition of fruquintinib to best supportive care improved overall survival compared with BSC alone in patients with metastatic colorectal cancer who progressed on standard chemotherapy and relevant biologic agents, and who had progressed on or were intolerant to trifluridine/tipiracil and/or regorafenib.

The robust efficacy achieved with tepotinib in patients with non–small cell lung cancer harboring MET exon 14 skipping alterations was independently confirmed in data from the primary analysis of cohort C of the phase 2 VISION trial.

The FDA has approved darolutamide tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.

The FDA has approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with unresectable or metastatic HER2-low breast cancer.

The FDA has approved a new tablet formulation of acalabrutinib for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and for those with relapsed or refractory mantle cell lymphoma.

The addition of pembrolizumab to lenvatinib did not significantly improve overall survival or progression-free survival over lenvatinib alone when used in the frontline treatment of patients with unresectable hepatocellular carcinoma, missing the dual primary end points of the phase 3 LEAP-002 trial.

The fully human BCMA-directed CAR T-cell therapy, CT103A, demonstrated deepening efficacy with an acceptable toxicity profile in patients with relapsed or refractory multiple myeloma, according to updated data from the phase 1/2 FUMANBA-1 trial.

As ongoing research efforts are shifting further into personalized care, Hope S. Rugo, MD, FASCO discusses how pathologic complete response and the predictive value of residual cancer burden scoring are becoming a pivotal end point for the changing triple-negative breast cancer landscape.