Web Exclusives

Intratumoral Administration of INT230-6 Improves Drug Diffusion and Uptake into Cancer Cells in Patients with Advanced Solid Tumors

A novel intratumoral chemotherapy agent delivered by direct injection permits the dispersion of cytotoxic drugs into cancer cells to eradicate tumors, according to data from a phase 1/2 trial of INT230-6 alone and in combination with pembrolizumab in patients with advanced solid tumors.

Intratumoral Administration of INT230-6 Improves Drug Diffusion and Uptake into Cancer Cells in Patients with Advanced Solid Tumors

A novel intratumoral chemotherapy agent delivered by direct injection permits the dispersion of cytotoxic drugs into cancer cells to eradicate tumors, according to data from a phase 1/2 trial of INT230-6 alone and in combination with pembrolizumab in patients with advanced solid tumors.

A Call to Focus on Financial Toxicity and Quality of Life in Genitourinary Malignancies

Delivering the keynote address at the 2020 Genitourinary Cancers Symposium, David F. Penson, MD, MPH, MMHC, Hamilton and Howd Chair in Urologic Oncology, Vanderbilt University Medical Center, Nashville, TN, highlighted the need to move toward patient-centered decisions beyond survival, focusing on patient-centered outcomes by integrating quality of life (QOL) and [ Read More ]

ctDNA May Be a Biomarker for Postsurgery MRD Positivity and Relapse in Patients with NSCLC

Data from the TRACERx lung study suggest that circulating tumor DNA (ctDNA) may be a biomarker for the detection of postsurgical minimal residual disease (MRD) in patients with non–small-cell lung cancer (NSCLC), suggesting which patients are at increased risk for disease relapse and will require more aggressive adjuvant therapy.

Luspatercept Effective in Patients with Lower-Risk Myelodysplastic Syndromes

Pivotal phase 3 data demonstrated treatment with luspatercept resulted in statistically significant increased red blood cell transfusion independence compared with placebo.

Tazverik Receives FDA Approval as First Treatment Specifically for Metastatic or Locally Advanced Epithelioid Sarcoma

On January 23, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of metastatic or locally advanced epithelioid sarcoma in adults and pediatric patients aged ≥16 years who are not eligible for complete resection.

FDA Grants Approval to Avapritinib for Patients with GIST

On January 9, 2020, the FDA approved avapritinib (Ayvakit; Blueprint Medicines), a kinase inhibitor, for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations, including PDGFRA D842V mutations.

Recap of FDA Drug Approvals in 2019

According to the FDA’s “Center for Drug Evaluation and Research (CDER) Annual Report: New Drug Therapy Approvals 2019,” the agency approved 48 novel drugs in 2019. Although this number does not approach the record of 59 approvals in 2018, it far surpasses the mere 22 approvals that occurred in 2016.

FDA Will Require Early Assessment of New Targeted Agents That May Be Used in Pediatric Cancers

On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.

Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma

On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug designation to the agent for the treatment of soft tissue sarcomas.

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