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FDA Updates: Approval Sought in Metastatic NSCLC; More Time Needed for Balstilimab
A filing for a bispecific antibody, and more time after a therapy gets more responses.
Amivantamab filing for Janssen. On Friday, Janssen announced it had submitted a biologics license application (BLA) seeking FDA approval for amivantamab for the treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations and disease progression, for patients who are on chemotherapy or have concluded platinum-based chemotherapy. Animvantamab is a bispecific antibody that targets both EGFR, which are very common in NSCLC, as well as mesenchymal epithelial transition (MET) factor. Submission is based on results from the phase I CHRYSALIS trial, which were presented at the American Society of Clinical Oncology virtual program in May. Findings showed a 36% overall response rate, including a 41% response rate in patients who had previously received platinum-based chemotherapy. Data from the trial also support creation of an expanded access program, allowing some patients to be treated while FDA weighs approval of the BLA.
Balstilimab BLA filing to be completed in early 2021. On Thursday, Agenus announced an updated timeline for submitting feedback that FDA seeks to complete its BLA filing for balstilimab, an investigational immunotherapy to treat recurrent or metastatic cervical cancer. FDA requires feedback on all patients for a median of 12 months and responders for a minimum of 6 months. Additional follow-up is now required to present data on 2 patients who experienced duration stabilization and “converted to confirmed responses on long-term balstilimab therapy,” the company said in a statement.
Reducing Low-Value Care in Oncology
November 10th 2023The Choosing Wisely campaign has helped with overscreening and overtreatment. Some experts say better management of end-of-life care and value-based payment would also help steer oncology away from care with poor cost-benefit ratios.
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Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
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Takeda to Withdraw Oncology Drug Exkivity from U.S. Market
October 2nd 2023In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.
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MHE Associate Editor, Briana Contreras, spoke with CEO of Inteliquet, a cancer solutions provider that strives to match patients to clinical trials accurately and promptly in healthcare, Marie Lamont. In this episode Marie discusses the challenges that have affected clinical trials and cancer screenings and how to get trials back on track through technology to avoid the wave of undiagnosed patients post-COVID. She also shared how broadening them through diversity can improve trials.
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