Kristi Rosa

Oncopeptides AB has made the decision to withdraw the indication of melphalan flufenamide in combination with dexamethasone in select adult patients with relapsed or refractory multiple myeloma from the US market.

The frontline combination of trifluridine/tipiracil and bevacizumab was not found to result in a significant improvement in progression-free survival over capecitabine and bevacizumab in patients with unresectable metastatic colorectal cancer who are not eligible to receive intensive therapy, missing the primary end point of the phase 3 SOLSTICE trial.

The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The FDA has approved the VENTANA PD-L1 assay to assist in identifying which adult patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on 1% or more of tumor cells are eligible to receive adjuvant atezolizumab following surgery and platinum-based chemotherapy.

Treatment with the small molecule oral immunomodulator EC-18 resulted in a reduction in both the duration and incidence of severe oral mucositis in patients with head and neck cancer who are undergoing concurrent chemoradiation.

The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.

Elacestrant monotherapy improved progression-free survival over standard-of-care (SOC) treatment in patients with estrogen receptor–positive, HER2-negative breast cancer, including those whose tumors harbored ESR1 mutations, meeting the primary end points of the phase 3 EMERALD trial.

Intravesical Bacillus Calmette–Guérin in combination with N-803 resulted in a 12-month disease-free survival rate of 57% in patients with BCG-unresponsive high-grade papillary non–muscle invasive bladder cancer, meeting the primary end point for cohort B of the phase 2/3 QUILT 3.032 trial.

The dismutase mimetic avasopasem manganese was not found to significantly reduce the incidence of severe oral mucositis in patients with locally advanced head and neck cancer who were receiving standard-of-care radiotherapy, missing the primary end point of the phase 3 ROMAN trial.

The bicycle toxin conjugates BT5528 and BT8009 have showcased preliminary signs of antitumor activity and encouraging tolerability when administered to patients with solid tumors such as urothelial cancer and ovarian cancer.

Inguinofemoral radiotherapy could potentially spare patients with vulvar cancer and sentinel node micrometastases from the morbidity of a lymphadenectomy.

The FDA has granted an orphan drug designation to LAVA-051, a CD1d-targeted Gammabody, for the treatment of patients with chronic lymphocytic leukemia.

The combination of sintilimab, a bevacizumab biosimilar injection, and chemotherapy resulted in a significant improvement in progression-free survival in patients with EGFR-mutated, nonsquamous, non–small cell lung cancer that as progressed following treatment with an EGFR TKI, meeting the primary end point of the phase 3 ORIENT-31 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding approval of the combination of pembrolizumab and lenvatinib for 2 indications: select patients with renal cell carcinoma and select patients with endometrial carcinoma.

A single, high priming dose of tremelimumab plus durvalumab resulted in a statistically significant and clinically meaningful improvement in overall survival vs sorafenib when used in the frontline treatment of patients with unresectable hepatocellular carcinoma who had not previously received systemic therapy and were not eligible for localized treatment.

The FDA has approved atezolizumab for use as an adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.

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 European Medicines Agency has approved a shorter, 90-minute infusion time for obinutuzumab to be given in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma.

The allogeneic CD19-targeted CAR T-cell therapy CTX110 was found to elicit encouraging responses with favorable tolerability in patients with relapsed or refractory B-cell malignancies, according to data from the phase 1 CARBON trial.

The FDA has approved pembrolizumab for use in combination with chemotherapy, with or without bevacizumab, in patients with persistent, recurrent or metastatic cervical cancer whose tumors have a PD-L1 combined positive score of 1 or higher, as determined by an FDA-approved test.

The 18-month survival rates observed with axitinib plus pembrolizumab vs ipilimumab plus nivolumab in the frontline treatment of patients with metastatic renal cell carcinoma were not found to be statistically different.

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.

Following a Type A meeting with the FDA to discuss deficiencies raised in a complete response letter pertaining to the new drug application for the use of oral paclitaxel encequidar in patients with metastatic breast cancer, the biopharmaceutical company Athenex, Inc. announced that their resources will be redeployed to focus on other studies examining oral paclitaxel.

The FDA has removed the full clinical hold that had previously been placed on trials evaluating rusfertide.

The FDA has granted a rare pediatric disease designation to lutetium-177-omburtamab-DTPA for use as a potential therapeutic option in pediatric patients with medulloblastoma, according to an announcement from Y-mAbs Therapeutics, Inc., the developer of the product.

The FDA has placed a hold on clinical trials examining Allogene Therapeutics, Inc.’s allogeneic CAR T-cell therapies for patients with cancer, following a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient who received treatment in the phase 1/2 ALPHA2 study.

The FDA has granted a breakthrough therapy designation to repotrectinib as a potential therapeutic option for patients with advanced solid tumors that harbor an NTRK gene fusion who have progressed after treatment with 1 or 2 prior TRK TKIs, with or without prior chemotherapy, and who have no satisfactory alternative options.

The FDA has granted a breakthrough therapy designation to trastuzumab deruxtecan-nxki for use in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 1 or more anti–HER2-based regimens.

The FDA has approved brexucabtagene autoleucel as a treatment for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.