Kristi Rosa

Osimertinib has emerged as the standard of care for patients with EGFR-mutated non–small cell lung cancer, but the need for novel agents is underscored as disease progression on the agent is inevitable.

The FDA has granted a fast track designation to eryaspase for use as a potential therapeutic option in patients with acute lymphocytic leukemia who have developed hypersensitivity reactions to Escherichia coli–derived pegylated asparaginase.

Zanubrutinib resulted in a significant improvement in progression-free survival per independent review committee assessment vs bendamustine plus rituximab in treatment-naïve patients with chronic lymphocytic leukemia whose tumors did not exhibit the deletion of chromosome 17p13.1.

The European Commission has approved nivolumab for use as an adjuvant treatment in adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after neoadjuvant chemoradiation.

The FDA has issued an alert that evidence from the phase 3 OCEAN study of melphalan flufenamide, which was recently approved for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma, has indicated that the doublet resulted in an increased risk of death in this population.

The addition of pembrolizumab to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival vs chemotherapy alone in patients with metastatic triple-negative breast cancer whose tumors had a PD-L1 expression of a combined positive score of 10 or higher, meeting the primary end point of the phase 3 KEYNOTE-355 trial.

The FDA has approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

Health Canada has approved the BTK inhibitor zanubrutinib for use in the treatment of adult patients with mantle cell lymphoma who have previously received at least 1 therapy.

Roche Registration GmbH has withdrawn its application to extend the use of atezolizumab to the treatment of patients with early or locally advanced triple-negative breast cancer in Europe.

The FDA has granted priority review to a new drug application for the nanoparticle albumin-bound mTOR inhibitor nab-sirolimus for the treatment of patients with malignant perivascular epithelioid cell neoplasm.

The FDA has issued a complete response letter to Incyte Corporation stating that it cannot approve the biologics license application for retifanlimab for use in adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy, in its present form.

The combination of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine with and without consolidative radiotherapy was found to have strong efficacy and favorable tolerability in patients with early-stage, unfavorable-risk, Hodgkin lymphoma.

Bristol Myers Squibb has decided to voluntarily withdraw the indication for nivolumab as a monotherapy for patients with hepatocellular carcinoma who were previously treated with sorafenib from the US market.

The FDA has granted a regular approval to pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, who have disease progression after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation.

The FDA has granted an orphan drug designation to alrizomadlin as a potential therapeutic option for patients with stage IIB-IV melanoma.

The safety and efficacy of the oral MDM2 inhibitor milademetan is under investigation vs trabectedin, a current standard of care, in the treatment of patients with dedifferentiated liposarcoma as part of the recently initiated phase 3 MANTRA trial.

The FDA has granted a breakthrough therapy designation to the combination of venetoclax plus azacitidine for use in the treatment of adult patients with previously untreated, intermediate-, high-, and very high–risk myelodysplastic syndromes based on the revised International Prognostic Scoring System.

The CCR5 antagonist leronlimab plus carboplatin was shown to result in a 72% decrease in cancer-associated macrophage-like cells, which was linked with an approximate 450% increase in overall survival in 30 patients with metastatic triple-negative breast cancer.

The novel gene-mediated immunotherapy GEN-1 showcased satisfactory safety with an acceptable risk/benefit profile when given over a 6-month period with up to 17 doses in newly diagnosed patients with stage III/IV ovarian cancer.

The Chinese National Medical Products Administration has approved durvalumab plus standard-of-care platinum chemotherapy, in the form of etoposide plus either carboplatin or cisplatin, as a frontline treatment option for patients with extensive-stage small cell lung cancer.

Belumosudil induced clinically meaningful, durable responses in patients with chronic graft-versus-host-disease, irrespective of previous treatment received, severity of disease, and number of organs involved.

The FDA has granted a fast track designation to trilaciclib for use in combination with chemotherapy in patients with locally advanced or metastatic triple-negative breast cancer

Ruxolitinib continued to result in a significant improvement in overall response rate compared with best available therapy in patients with steroid-refractory/dependent chronic graft-vs-host disease, regardless of the individual organs involved at baseline.

The FDA has approved the FoundationOne Liquid CDx for use as a companion diagnostic to assist in the identification of patients with metastatic non–small cell lung cancer whose tumors harbor MET exon 14 skipping mutations and who could derive benefit from treatment with capmatinib.

The FDA has approved belumosudil for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease following failure of at least 2 prior lines of systemic therapy.

A Late-Cycle Meeting was held to discuss the biologics license application for Vicineum as a potential option for patients with Bacillus Calmette-Guérin–unresponsive non-muscle invasive bladder cancer.

Nivolumab plus ipilimumab did not significantly improve overall survival over the EXTREME regimen in the frontline treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck, missing the primary end points of the phase 3 CheckMate-651 trial.

Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant single-agent pembrolizumab was found to significantly improve event-free survival over neoadjuvant chemotherapy followed by adjuvant placebo in patients with high-risk, early-stage triple-negative breast cancer.

The combination of atezolizumab plus bevacizumab elicited encouraging, durable responses in patients with advanced malignant peritoneal mesothelioma, irrespective of tumor mutational burden and PD-L1 expression status.

The FDA has lifted a partial clinical hold that was placed on a first-in-human, phase 1b trial evaluating RVU120 in patients with relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.