
The FDA has granted an orphan drug designation to PBI-200 for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors.

Chris Ryan joined OncLive in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: [email protected]

The FDA has granted an orphan drug designation to PBI-200 for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors.

Praluzatamab ravtansine achieved a promising overall response rate in patients with advanced hormone receptor–positive, HER2-negative breast cancer.

The addition of tislelizumab to nab-paclitaxel demonstrated efficacy and safety in patients with high-risk non–muscle invasive bladder cancer.

The FDA has warned that treatment with duvelisib has shown a possible increased risk of death and serious adverse effects compared with ofatumumab in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.

Philip A. Philip, MD, PhD, FRCP, discusses unmet needs for patients with pancreatic cancer, emerging targets and agents in the space, and his hopes for future developments in the field.

Socazolimab produced encouraging response rates with an acceptable safety profile in patients with recurrent or metastatic cervical cancer, irrespective of PD-L1 status, according to findings from the dose-expansion portion of a phase 1 trial.

The European Commission has granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory follicular lymphoma after 3 or more prior lines of systemic therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of trastuzumab deruxtecan monotherapy for patients with metastatic HER2-positive breast cancer who have received at least 1 prior anti–HER2-based regimen.

Adjuvant treatment with TX05 resulted in a similar disease-free survival benefit to that of trastuzumab in patients with early-stage HER2-positive breast cancer.

The European Commission has approved pembrolizumab for adjuvant treatment of adult and adolescent patients 12 years and older with stage IIB or IIC melanoma who have undergone a complete resection.

The CAR T-cell therapy ciltacabtagene autoleucel generated a high response rate in patients with multiple myeloma who experienced early clinical relapse or failure to initial therapy.

Sikander Ailawadhi, MD, discusses early efficacy observed with iopofosine I-131, the rationale of investigating the agent in the CLOVER WaM trial in patients with Waldenström macroglobulinemia, and how the radiotherapeutic could affect the treatment paradigm.

The European Medicines Agency's Committee for Medicinal Products for Human Use has unanimously recommended full marketing authorization approval of melphalan flufenamide for patients with triple-class refractory multiple myeloma.

The FDA has granted an orphan drug designation to VBI-1901, a novel cancer immunotherapeutic vaccine candidate, as a potential therapeutic option for patients with glioblastoma.

The FDA has granted an orphan drug designation to PT217 for use as a potential therapeutic option for patients with small cell lung cancer.

The antibody-drug conjugate farletuzumab ecteribulin demonstrated notable antitumor activity with a manageable safety profile in patients with platinum-resistant ovarian cancer.

Nemtabrutinib, a potent, non-covalent BTK inhibitor, continued to demonstrate antitumor activity with an acceptable safety profile in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

A single infusion of the CAR T-cell therapy ciltacabtagene autoleucel produced deep and durable responses in patients with relapsed/refractory multiple myeloma with a manageable toxicity profile, according to long-term follow-up data of the phase 1b/2 CARTITUDE-1 trial.

The China National Medical Products Administration’s Center for Drug Evaluation granted 2 breakthrough therapy designations to repotrectinib for the treatment of patients with ROS1-positive metastatic non–small cell lung cancer.

The FDA has granted a fast track designation to dianhydrogalactitol for the treatment of patients with newly-diagnosed unmethylated glioblastoma.

Single-agent navitoclax achieved a manageable safety profile compared with navitoclax plus ruxolitinib in patients with myelofibrosis. However, efficacy results, specifically at 24 weeks of treatment, favored the combination over navitoclax monotherapy.

Next-generation panel sequencing and a unique algorithm demonstrated the advantage of detecting NRG1 fusions and providing structure information of partners, which could ultimately guide more precise therapeutic options, according to data from a study done in Chinese patients with solid tumors.

Treatment with ropeginterferon alfa-2b-njft induced low symptom burden and low phlebotomy requirement compared with best available treatment in patients with polycythemia vera, according to long-term data from the phase 3 PROUD-PV and CONTINUATION-PV trials.

Treatment with the R-CODOX-M and R-IVAC regimens elicited similar efficacy to dose-adjusted infused DA-EPOCH-R in patients with newly diagnosed, high-risk Burkitt lymphoma.

ARI0002H, a BCMA-directed CAR T-cell therapy, achieved promising response rates in patients with relapsed/refractory multiple myeloma, according to findings from a phase 1/2 trial.

Oral azacitidine was associated with improved long-term survival in patients with acute myeloid leukemia who harbored NPM1 mutations, had intermediate-risk cytogenetics at diagnosis, had a longer treatment duration, or a minimal residual disease response during treatment.

Adding toripalimab to chemotherapy in the frontline setting demonstrated improved progression-free survival vs placebo plus chemotherapy in patients with advanced non–small cell lung cancer without EGFR or ALK mutations, regardless of PD-L1 status.

Zanubrutinib continued to demonstrate a higher complete response or very good partial response rate and less off-target activity compared with ibrutinib in patients with MYD88-mutated Waldenström macroglobulinemia.

Seribantumab was found to produce encouraging overall response rates with acceptable tolerability when used as a monotherapy in patients with solid tumors harboring NRG1 fusions.

The use of BTK inhibitors as a frontline treatment improved overall survival vs their deployment in subsequent lines of therapy in patients with mantle cell lymphoma, according to a real-world study (IRB-300004501) published in Blood Advances.