PLEURAL DISEASES MARKET ANALYSIS

Market News

New product approvals

• On August 8, 2023, Boston Scientific Corporation, a medical device company, announced it had received U.S. Food and Drug Administration (FDA) approval for the POLARx Cryoablation System. The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF).
• On June 14, 2023, Amneal Pharmaceuticals, Inc., a pharmaceutical company, announced the 505(b) (2) New Drug Application (NDA) approval from the U.S. Food and Drug Administration for PEMRYDI RTU. This product is indicated for treating non-squamous non-small cell lung cancer and malignant pleural mesothelioma.
• On March 10, 2023, Merck & Co., Inc., a pharmaceutical company, announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
• In February 2021, Bristol Myers Squibb, a pharmaceutical company, announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).

 Research and Development Activities

• In May 2022, Oncotelic Inc., a developer of treatments for rare and orphan indications, including Parkinson Disease and various cancers, announced the clearance of the Phase 2 clinical trial protocol for mesothelioma after filing the protocol to the Food and Drug Administration.
• In April 2022, the study titled “IFN-γ Combined with T Cells in the Treatment of Refractory Malignant Pleural Effusion and Ascites” was registered in ClinicalTrials.gov for Malignant Pleural Effusion
• In September 2021, Bristol Mayer Squibb declared three-year data from the CheckMate -743 trial. As per the clinical trial data, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism.