FDA Grants Fast Track Designation to Reolysin for Metastatic Breast Cancer

Excerpt:

“The FDA granted fast track designation to pelareorep for the treatment of metastatic breast cancer, according to the drug’s manufacturer.

“Pelareorep (Reolysin, Oncolytics Biotech) is an immuno-oncology viral-agent designed to induce selective tumor lysis, and promote an inflamed tumor phenotype through innate and adaptive immune responses, according to a company-issued press release.

“An open-label, randomized phase 2 study evaluated the addition of IV pelareorep to paclitaxel for patients with advanced or metastatic breast cancer.”

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FDA Grants Fast Track Designation to ImmunoPulse IL-12 for Melanoma

Excerpt:

“The FDA granted fast track designation to ImmunoPulse IL-12 for the treatment of metastatic melanoma that progressed during therapy with pembrolizumab or nivolumab.

“ImmunoPulse IL-12 (OncoSec Medical) is an intratumoral anticancer gene therapy that expresses interleukin-12 (IL-12).

“ ‘With the number of melanoma patients now being treated with either pembrolizumab (Keytruda, Merck) or nivolumab (Opdivo, Bristol Myers Squibb) in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy,’ Punit Dhillon, president and CEO of OncoSec, said in a company-issued press release. ‘Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies.’ ”

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Merrimack Pharmaceuticals : FDA Grants Merrimack Fast Track Designation for Seribantumab (MM-121) in Non-small Cell Lung Cancer

Excerpt:

“Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced that the U.S. Food and Drug Administration (FDA) has granted seribantumab, also known as MM-121, Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy. Fast Track is a program designed by the FDA to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. Merrimack is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC that is designed to support a Biologics License Application to the FDA. Seribantumab is Merrimack’s wholly owned, fully human monoclonal antibody that targets ErbB3.”

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FDA Grants Fast Track Designation to Sacituzumab Govitecan for NSCLC

“The FDA granted fast track designation to sacituzumab govitecan for the treatment of patients with metastatic non–small cell lung cancer, according to a press release from the drug’s manufacturer.

“Sacituzumab govitecan (IMMU-132, Immunomedics) — a next-generation antibody-drug conjugate of the moderately toxic drug SN-38, the active metabolite of irinotecan — is intended for patients with metastatic NSCLC who have failed two prior lines of therapy, such as ALK, EGFR and PD-1 inhibitors.

“Sacituzumab govitecan has shown promise in a mid-stage clinical study for patients with metastatic solid cancers — including breast, lung, esophageal, colorectal, and urinary bladder cancers — who failed multiple prior therapies. Patients experienced limited and tolerable side effects, according to the press release.

“Previously, the FDA granted fast track status to sacituzumab govitecan for the treatment of patients with triple-negative breast cancer and small-cell lung cancer. In addition, sacituzumab govitecan received FDA orphan drug designation for the treatment of small-cell lung cancer and pancreatic cancer.”


FDA Grants Fast Track Status to IMMU-132 for Triple-Negative Breast Cancer

The gist: The U.S. Food and Drug Administration (FDA) has granted a “Fast-Track” designation to a new treatment for people with metastatic, triple-negative breast cancer who haven’t had success with their previous treatments. The treatment is called sacituzumab govitecan (aka IMMU-132). The Fast-Track designation means that the FDA will facilitate a faster approval process so that the treatment can soon be prescribed by oncologists in the U.S.

“The FDA today granted fast track status to sacituzumab govitecan, an antibody–drug conjugate in development for treatment of patients with triple-negative breast cancer who failed prior therapies for metastatic disease, according to the drug’s manufacturer.

“Sacituzumab govitecan (IMMU-132, Immunomedics) is formed by using the moderately-toxic SN-38 — the active metabolite of irinotecan (Camptosar; Pfizer), used to treat certain solid tumors — conjugated to an anti–TROP-2 antibody.

“The FDA’s Fast Track program is intended to facilitate the development and expedite the review of new drugs intended to treat serious conditions, as well as agents that would fill unmet medical needs.

“The FDA based its decision on the efficacy sacituzumab govitecan has shown in patients with advanced triple-negative breast cancer.


FDA Grants Fast Track Designation to PEGPH20 Program for Metastatic Pancreatic Cancer

Editor’s note: The U.S. Food and Drug Administration (FDA) has granted a “Fast-Track” designation to a new treatment for people with advanced pancreatic cancer. The treatment combines the drugs PEGPH20, gemcitabine, and nab-paclitazel. The Fast-Track designation means that the FDA will facilitate a faster approval process so that the treatment can soon be prescribed by oncologists in the U.S.

“The FDA granted fast track designation today to Halozyme Therapeutics for its PEGPH20 program in treating patients with pancreatic cancer, according to a company press release.

The program seeks to demonstrate improved overall survival in metastatic pancreatic cancer patients by studying the use of pegylated recombinant human hyaluronidase in combination with gemcitabine and nab-paclitaxel.

“The FDA’s fast track designation for our PEGPH20 program in pancreatic cancer underscores the significant need for new treatment options for pancreatic cancer patients with advanced disease,” Helen Torley, MD, Halozyme president and CEO, said in the release. “We look forward to continuing to work with the FDA on this program to explore whether patients with metastatic pancreatic cancer can benefit from this therapy.”


VentiRx Pharmaceuticals Announces Fast Track Designation Granted for Motolimod (VTX-2337), a Novel Immunotherapy for Women with Ovarian Cancer

Editor’s note: The U.S. Food and Drug Administration (FDA) has granted a “Fast Track” designation to a new drug for certain patients with ovarian cancer. The drug, motolimod (aka VTX-2337), is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer. It is meant to treat women whose ovarian cancer worsened during or recurred after platinum-based chemotherapy. The Fast-Track designation means that the FDA will facilitate a faster approval process so that the drug can soon be prescribed by oncologists in the U.S.

“VentiRx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company committed to the development and commercialization of novel Toll-like receptor 8 (TLR8) immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy.  Motolimid is a novel TLR8 immunotherapy currently being evaluated in two randomized, placebo-controlled Phase 2 trials.

“FDA Fast Track Designation is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application (NDA) for drugs with the potential to treat serious or life-threatening conditions and address unmet medical needs.

” ‘The Fast Track designation is an important regulatory milestone for the motolimod (VTX-2337) program and underscores the potential for this novel agent to address a significant unmet medical need for women with ovarian cancer who have progressed on or recurred after receiving platinum-based chemotherapy,’ said Robert Hershberg, MD, PhD, President and CEO of VentiRx. ‘We look forward to emerging clinical data and to the possibility of providing a meaningful treatment for women with ovarian cancer.”‘ “


Agios Gets FDA Fast-Track Designation for its Experimental Leukemia Drug

Editor’s note: The U.S. Food and Drug Administration (FDA) has granted a “Fast-Track” designation to a new drug for certain patients with acute myelogenous leukemia (AML). The drug, called AG-221, is a targeted therapy that is meant to treat people with AML whose tumors have mutations in the isocitrate dehydrogenase-2 protein (IDH2), as detected by molecular testing. The Fast-Track designation means that the FDA will facilitate a faster approval process so that the drug can soon be prescribed by oncologists in the U.S.

“Agios Pharmaceuticals Inc., a Cambridge company seeking to develop new treatments for cancer, said Wednesday that the US Food and Drug Administration has granted a so-called “Fast Track” designation to its experimental treatment for a type of acute myelogenous leukemia, or AML.

“The FDA’s fast track program is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application, or NDA. The designation is given to medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The program provides the opportunity to submit sections of a new drug application on a rolling basis as data become available. This permits the FDA to review portions of the new drug application as they are received instead of waiting for the entire application submission.

“Agios currently calls its drug candidate AG-221, and it is designed to the treat patients with AML who harbor an isocitrate dehydrogenase-2 mutation.”


AstraZeneca Seeking to Get Cancer Drugs to Patients Early

“British patients could benefit from AstraZeneca’s promising new cancer drugs well before they complete clinical testing, the Telegraph can reveal.

“Pascal Soriot, chief executive, told the Telegraph he was looking to make two of Astra’s most eye-catching cancer drugs widely available to patients as soon as possible.

“Britain’s recently launched early access to medicines scheme, which aims to get drugs to patients years earlier than the normal regulatory process allows, is among the programmes in Mr Soriot’s sights. The US, France and Japan have also established pathways to fast-track promising new drugs to patients ahead of final regulatory approval.”