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The Reporting of Adverse Events in Oncology Phase III Trials

A study comparing the current status of adverse events (AEs) reporting in oncology phase III trials with the expectations of the European Organization for Research and Treatment of Cancer (EORTC) membership reveals significant discrepancies. While most reports include grade 3/4 AEs, there's a lack of comprehensive reporting on grade 5 AEs, AEs leading to study withdrawal, and dose reduction, contrary to EORTC members' expectations.

FDA Approves Record 45 New Drugs in 2015, Led by Breakthrough Cancer Immunotherapy Opdivo

  • The FDA approved 45 new drugs in 2015, marking a significant rise in R&D productivity, with Bristol-Myers Squibb's immunotherapy Opdivo leading the pack with five new indications for various cancers.
  • Novel treatments like Vertex's Orkambi for cystic fibrosis and Novartis's Entresto for heart failure demonstrated remarkable clinical innovation, though pricing concerns remained central to industry discussions.
  • The year saw major developments in drug pricing debates, with the emergence of ICER as an independent US cost-effectiveness watchdog and increased scrutiny of pharmaceutical pricing practices.

Sanofi and Boehringer Ingelheim Announce €11.4B Asset Swap Deal to Reshape Consumer Health Market

  • Sanofi will acquire Boehringer Ingelheim's consumer health division valued at €6.7B, while divesting its animal health business Merial for €11.4B, positioning Sanofi as the global leader in consumer healthcare.
  • The strategic exchange includes a €4.7B cash payment to Sanofi from Boehringer Ingelheim, with the combined deal expected to create a consumer health business generating approximately €5.1B in annual revenue.
  • The asset swap, set to close in Q4 2016, maintains workforce stability with minimal redundancies planned, requiring regulatory approval and union consultation before completion.

Novel Cancer Drug Development Pipeline Shows Promise Across Multiple Therapeutic Areas

  • Recent advances in oncology drug development have shown significant progress across multiple cancer types, with several promising candidates entering late-stage clinical trials.
  • Pharmaceutical companies are increasingly focusing on targeted therapies and precision medicine approaches, leading to more personalized treatment options for cancer patients.
  • New drug development strategies are addressing previously challenging cancer targets, with improved efficacy and safety profiles compared to conventional treatments.

The BWEL Trial: A Study on Weight Loss and Breast Cancer Recurrence

The Breast Cancer Weight Loss (BWEL) trial investigates the impact of weight loss on reducing cancer recurrence in overweight or obese women with stage II-III breast cancer. This randomized, controlled trial compares a telephone-based weight loss intervention plus health education materials against health education materials alone, aiming for a ≥10% weight loss through increased physical activity and caloric restriction.

Breast Cancer WEight Loss Study (BWEL Study)

NCT02750826Active, Not RecruitingPhase 3
Alliance for Clinical Trials in Oncology
Posted 9/16/2016

Palbociclib Plus Letrozole Approved for First-Line ER+, HER2- Metastatic Breast Cancer

  • Palbociclib, a CDK4/6 inhibitor, received FDA accelerated approval in combination with letrozole for postmenopausal women with ER+, HER2- metastatic breast cancer.
  • The approval was based on the PALOMA-1 trial, which demonstrated improved progression-free survival compared to letrozole alone in previously untreated patients.
  • Common adverse events associated with the combination therapy include neutropenia, leukopenia, and fatigue, requiring careful monitoring and dose adjustments.
  • Clinicians should consider toxicities, quality-of-life issues, and cost when making treatment decisions, as alternative regimens with different toxicity profiles exist.

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135CompletedPhase 3
Pfizer
Posted 9/26/2013

PD 0332991 and Cetuximab in Patients With Incurable SCCHN

NCT02101034CompletedPhase 1
Washington University School of Medicine
Posted 6/17/2014

A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma

NCT01227434TerminatedPhase 2
University of California, San Francisco
Posted 9/1/2010

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

NCT01864746CompletedPhase 3
German Breast Group
Posted 10/30/2013

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

NCT00555906CompletedPhase 2
Pfizer
Posted 1/1/2008

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

NCT01740427CompletedPhase 3
Pfizer
Posted 2/22/2013

Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

NCT00721409CompletedPhase 2
Pfizer
Posted 9/15/2008

FDA Approves Trofinetide for Rett Syndrome Treatment

The US Food and Drug Administration (FDA) has approved trofinetide, a synthetic analog of glycine-proline-glutamate (GPE), for the treatment of Rett syndrome (RTT) in adults and pediatric patients aged 2 years and older. This approval marks a significant milestone in the treatment of RTT, a rare neurodevelopmental disorder, following years of scientific and clinical research.

India Modernizes Clinical Trial Process with Digital System and Mandatory AV Consent Recording

  • India's Central Drugs Standard Control Organisation (CDSCO) launches new IT-enabled system to streamline clinical trial applications, improving transparency and efficiency in trial registration process.
  • Mandatory audiovisual recording of informed consent has been implemented across 90% of Indian trial sites, addressing previous concerns about participant protection and ethical standards.
  • The initiatives aim to bridge the gap between Indian and international clinical trial standards, leveraging India's vast treatment-naïve population of over a billion people across 500+ sites.

Smoking Poses Heightened Health Risks for HIV Patients, Studies Show

  • Recent studies reveal that people living with HIV who smoke lose more years of life from smoking than from HIV itself, with 50-70% of HIV-positive individuals being smokers.
  • Smoking significantly increases HIV patients' risk of opportunistic infections, cardiovascular disease, and medication complications, with up to 60% higher mortality rates observed in smokers.
  • Public health initiatives like Stoptober and e-cigarette adoption are being promoted as harm reduction strategies, with evidence showing e-cigarettes carry only 5% of tobacco's health risks.

FDA Draft Guidance Clarifies Requirements for Confirmatory Trials Under Accelerated Approval

  • The FDA has issued draft guidance on accelerated approval, focusing on when confirmatory trials must be 'underway'.
  • This guidance interprets 'underway' and details factors the FDA will consider before granting accelerated approval.
  • The guidance aims to ensure timely completion of confirmatory trials, as mandated by the Consolidated Appropriations Act of 2023.
  • Stakeholders can submit comments on the draft guidance until March 10, 2025, for consideration by the FDA.
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