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COTA Signs Agreement with FDA for Breast Cancer Research

In Clinical Trials by Barbara Jacoby

By: Drew Boxler From: drugtopics.com COTA Inc, a precision medicine technology company that uses real-world evidence (RWE) to bring clarity to cancer care, has signed an agreement with FDA’s science and technology incubator, Information Exchange and Data Transformation Program (INFORMED). The agreement will bring real-world evidence to the development of breast cancer treatments. Under the two-year research collaboration agreement, COTA …

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FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

In Clinical Trials by Barbara Jacoby

From: fda.gov June 10, 2019 Today, the U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. Polivy is a novel antibody-drug …

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FDA Officials Call for Patient-Friendly Terminology in Oncology

In Clinical Trials by Barbara Jacoby

By: Michael Mezher  From: raps.org Officials from the US Food and Drug Administration’s (FDA) oncology offices say they plan to develop a glossary of patient-friendly terms and definitions for oncology clinical trial endpoints. In a paper published earlier this month in The Oncologist, officials from FDA’s Oncology Center of Excellence and Office of Hematology and Oncology Products make the case …

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BioTheryX Announces FDA approval of IND Application to Initiate Phase I Clinical Trial in Relapsed or Refractory Acute Myeloid Leukemia

In Clinical Trials by Barbara Jacoby

Expects Enrollment of Phase I Trial to Begin in the Third Quarter of 2019 BioTheryX, Inc. (“BioTheryX”), a biotechnology company creating new classes of drugs based on multi-kinase inhibition and targeted protein degradation, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared BioTheryX’s investigational new drug application (“IND”) for BTX-A51, an oral multi-kinase inhibitor, for the treatment …

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Leveraging Real World Evidence for drug approval

In Clinical Trials by Barbara Jacoby

By: Andrew Burrows From: knect365.com In 2016 the FDA introduced the 21st Century Cures Act, which allowed for the expansion of real world evidence in gaining approvals for new drugs. Following this Pfizer’s Ibrance, a CDK 4/6 inhibitor, was recently approved for the treatment of breast cancer in men by leveraging real world evidence. Whilst there are clearly exciting opportunities around the use …

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FDA grants fast track designation to leronlimab for metastatic triple-negative breast cancer

In Clinical Trials by Barbara Jacoby

From: healio.com The FDA granted fast track designation to leronlimab for use in combination with carboplatin for the treatment of patients with CCR5-positive metastatic triple-negative breast cancer. Leronlimab (PRO 140, CytoDyn Inc.) is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor believed to play key roles in tumor invasion and metastasis. Agents that block CCR5 have …

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FDA’s Project Facilitate to Launch by End of May

In Clinical Trials by Barbara Jacoby

By: Mark Terry From: biospace.com The U.S. Food and Drug Administration (FDA) held a public workshop yesterday to explain its goals and progress on Project Facilitate. Project Facilitate is a pilot project to create a single point of contact for the FDA’s oncology expanded access requests. In order to do so, the FDA will run a call center to help …

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Intensity Therapeutics Receives Fast Track Designation from U.S. FDA for Development of INT230-6 as Treatment for Relapsed or Metastatic Triple Negative Breast Cancer

In Clinical Trials by Barbara Jacoby

Source: Intensity Therapeutics Inc From: globenewswire.com Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s development program evaluating INT230-6 for the treatment of patients with relapsed …

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Are You Dense?

In In The News by Barbara Jacoby

By: Bonnie Annis From: curetoday.com Are you dense? I’m not referring to your mental abilities, I’m referring to your breasts. Have you felt them lately? I’m very concerned with your answer and so is the Food and Drug Administration (FDA), it seems. For the first time in over 20 years, the FDA feels amendments to current regulations would not only improve …

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Novel Agent Granted Orphan Drug Designation for T-Cell Prolymphocytic Leukemia

In Clinical Trials by Barbara Jacoby

By: Audrey Sternberg From: targetedonc.com Investigational agent tinostamustine (EDO-S101), a first-in-class alkylating deacetylase inhibiting molecule, has been granted orphan drug designation by the FDA for the treatment of patients with T-cell prolymphocytic leukemia (T-PLL).1 “This orphan drug designation represents an important step…for patients suffering from T-PLL who do not currently have sufficient treatment options,” said Richard Fanelli, PhD, head of …