Regulatory – Melanoma Research Victoria https://melanomaresearchvic.com.au Thu, 21 Jan 2021 04:51:29 +0000 en-US hourly 1 https://melanomaresearchvic.com.au/wp-content/uploads/2017/12/cropped-favicon-32x32.png Regulatory – Melanoma Research Victoria https://melanomaresearchvic.com.au 32 32 FDA Grants Orphan Drug Designation to Novel Immunotherapy in Advanced Melanoma https://melanomaresearchvic.com.au/fda-grants-orphan-drug-designation-to-novel-immunotherapy-in-advanced-melanoma Mon, 25 Jan 2021 04:48:28 +0000 https://melanomaresearchvic.com.au/?p=16257 The FDA has granted an Orphan Drug designation to the novel immunotherapy PVSRIPO for the treatment of patients with advanced melanoma of stage IIB-IV, Istari Oncology, Inc., announced in a press release.1

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Source: Targeted Oncology, January 2021

The FDA has granted an Orphan Drug designation to the novel immunotherapy PVSRIPO for the treatment of patients with advanced melanoma of stage IIB-IV, Istari Oncology, Inc., announced in a press release.1

The agent is under evaluation currently in a phase 2 study known as LUMINOS-102 (NCT04577807), which follows a successful phase 1 study of PVSRIPO as monotherapy in patients with anti-PD-1 refractory advanced melanoma.

“We are encouraged by the data from our phase 1 trial presented at last year’s Society for Immunotherapy of Cancer (SITC) 2020 annual meeting,” said Garrett Nichols, MD, MS, chief medical officer, Istari Oncology, in a statement.

READ THE ORIGINAL FULL ARTICLE

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Istari Oncology Announces FDA Clearance of New IND to Open LUMINOS-102: PVSRIPO with and without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma https://melanomaresearchvic.com.au/istari-oncology-announces-fda-clearance-of-new-ind-to-open-luminos-102-pvsripo-with-and-without-immune-checkpoint-blockade-in-advanced-pd-1-refractory-melanoma Thu, 24 Dec 2020 04:00:29 +0000 https://melanomaresearchvic.com.au/?p=16100 Istari Oncology, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) for a Phase 2 clinical trial, LUMINOS-102, to investigate the efficacy and safety of PVSRIPO alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor in patients with treatment-refractory […]

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Source: businesswire, November 2020

Istari Oncology, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) for a Phase 2 clinical trial, LUMINOS-102, to investigate the efficacy and safety of PVSRIPO alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor in patients with treatment-refractory melanoma.

PVSRIPO is a novel viral immunotherapy that activates a patient’s innate and adaptive immunity to facilitate a targeted anti-tumor immune response.

Following positive Phase 1 results in patients with unresectable and/or metastatic melanoma, the new IND will enable continued development of PVSRIPO for advanced melanoma.

READ THE ORIGINAL FULL ARTICLE

 

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Melanoma Research Alliance Hails FDA’s First ‘Triplet’ Combination Approval for Melanoma https://melanomaresearchvic.com.au/melanoma-research-alliance-hails-fdas-first-triplet-combination-approval-for-melanoma Thu, 10 Sep 2020 08:52:38 +0000 https://melanomaresearchvic.com.au/?p=15579 The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the decision by the U.S. Food and Drug Administration (FDA) approving Genentech’s Tecentriq ® (atezolizumab) plus Cotellic ® (cobimetinib) and Zelboraf ® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.

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Source: businesswire, August 2020

The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the decision by the U.S. Food and Drug Administration (FDA) approving Genentech’s Tecentriq ® (atezolizumab) plus Cotellic ® (cobimetinib) and Zelboraf ® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.

The newly approved triplet treatment is the first FDA-approved combination for metastatic melanoma that brings together immunotherapy with targeted therapies. Tecentriq, an immunotherapy, works by releasing the brakes on the immune system allowing it to attack cancerous cells. Cotellic and Zelboraf are targeted therapies that shut down specific pathways used by cancer to grow. Mutated copies of the BRAF V600 protein are found in about half of all melanomas.

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FDA Grants Fast Track Designation to CMP-001 Combination in Advanced Melanoma https://melanomaresearchvic.com.au/fda-grants-fast-track-designation-to-cmp-001-combination-in-advanced-melanoma Mon, 03 Aug 2020 08:49:04 +0000 https://melanomaresearchvic.com.au/?p=15430 The FDA has granted Fast Track designation to CMP-001 in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy), which will undergo clinical trial development both as a potential extender of time to disease relapse as an initial treatment of patients with unresectable stage III or stage IV melanoma, as well as to improve the overall tumor […]

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Source: Targeted Oncology, July 2020

The FDA has granted Fast Track designation to CMP-001 in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy), which will undergo clinical trial development both as a potential extender of time to disease relapse as an initial treatment of patients with unresectable stage III or stage IV melanoma, as well as to improve the overall tumor response rate as treatment of patients with unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade.1

Before this regulatory action, CMP-001 was granted Orphan Drug designation for IIB/IV melanoma.

“These FDA designations for CMP-001 are testaments to the critical need for new drugs designed to treat patients with melanoma,” said Barry Labinger, CEO of Checkmate. “We look forward to continued engagement with the FDA in advancing the development of CMP-001 in combination with PD-1 blockade in melanoma and head and neck squamous cell carcinoma.”

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Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L https://melanomaresearchvic.com.au/polynoma-receives-fda-fast-track-designation-for-its-melanoma-cancer-vaccine-seviprotimut-l Fri, 17 Jul 2020 05:00:06 +0000 https://melanomaresearchvic.com.au/?p=15350 Polynoma LLC, announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L.

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Source: PR Newswire, June 2020

SAN DIEGO, June 23, 2020 /PRNewswire/ — Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L, its melanoma cancer vaccine for the adjuvant treatment of stage IIB/IIC melanoma patients post-resection to improve recurrence-free survival.

“The Fast Track designation by the FDA provides further validation of seviprotimut-L as a potential new and important cancer vaccine for patients with localized melanoma,” said Alan Yu, Chairman of Polynoma and Vice President & Chief Operating Officer at CK Life Sciences. “We look forward to advancing seviprotimut-L in a pivotal trial as an adjuvant treatment of melanoma.”

Fast Track is designed to facilitate the development and expedite the review of drugs which treat serious or life-threatening conditions and fill an unmet medical need.

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NKTR-214 with Opdivo Earns FDA’s Breakthrough Therapy Designation for Advanced Melanoma https://melanomaresearchvic.com.au/nktr-214-with-opdivo-earns-fdas-breakthrough-therapy-designation-for-advanced-melanoma Tue, 15 Oct 2019 21:00:51 +0000 https://melanomaresearchvic.com.au/?p=14138 The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy NKTR-214 with Opdivo (nivolumab) for untreated melanoma patients with either metastatic disease or who are unable to undergo surgery.

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Source: Immuno-oncology, October 2019

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy NKTR-214 with Opdivo (nivolumab) for untreated melanoma patients with either metastatic disease or who are unable to undergo surgery.

A global Phase 3 clinical trial (NCT03635983) comparing the effectiveness and safety of add-on NKTR-214 to Opdivo alone in first-line treatment of advanced melanoma patients is currently enrolling. More information on contacts, open locations and those yet to open can be found here.

NKTR-214, or bempegaldesleukin, is Nektar Therapeutics’ lead immuno-oncology candidate. It works by promoting the activation and proliferation of a subset of immune T-cells and natural killer (NK) cells, both capable of eliminating cancer cells.

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Bempegaldesleukin Plus Nivolumab Granted Breakthrough Designation in Melanoma by the FDA https://melanomaresearchvic.com.au/bempegaldesleukin-plus-nivolumab-granted-breakthrough-designation-in-melanoma-by-the-fda Wed, 18 Sep 2019 22:00:34 +0000 https://melanomaresearchvic.com.au/?p=13971 The combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) was granted a breakthrough therapy designation by the FDA for the treatment of patients with previously untreated unresectable or metastatic melanoma.

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Source: Targeted Oncology, September 2019

The combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) was granted a breakthrough therapy designation by the FDA for the treatment of patients with previously untreated unresectable or metastatic melanoma.

The combination of  bempegaldesleukin and nivolumab led to an overall response rate (ORR) of 53% by independent radiology review, which included a 34% complete response (CR) rate, in this patient population in a cohort of the ongoing phase I/II PIVOT-02 trial, which is the basis for the FDA deisgination.

“In collaboration with our partner Bristol-Myers Squibb, we plan to work closely with FDA as we continue to advance our development program of bempegaldesleukin in combination with nivolumab in advanced melanoma patients,” Stephen Doberstein, PhD, SVP, Research and Development and Chief R&D Officer of Nektar Therapeutics, stated in a press release. “Our teams are encouraged by the deepening of responses we observed in patients with previously untreated advanced melanoma who received the doublet therapy in our PIVOT-02 study. We look forward to continuing to provide updated results at a future medical meeting as the data mature further from this ongoing cohort of melanoma patients.”

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FDA Approval in TGCT, Breakthrough Designation in Melanoma, and More https://melanomaresearchvic.com.au/fda-approval-in-tgct-breakthrough-designation-in-melanoma-and-more Thu, 05 Sep 2019 22:00:27 +0000 https://melanomaresearchvic.com.au/?p=13904 An FDA approval in tenosynovial giant cell tumor, a breakthrough therapy designation in melanoma, and encouraging findings in trials in bladder cancer, lung cancer, and a cell-free DNA assay.

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Source: OncLive, September 2019


An FDA approval in tenosynovial giant cell tumor, a breakthrough therapy designation in melanoma, and encouraging findings in trials in bladder cancer, lung cancer, and a cell-free DNA assay.

Welcome to OncLive News Network! I’m Kristi Rosa.

The FDA has approved pexidartinib, known by the trade name Turalio, for the treatment of adult patients with symptomatic tenosynovial giant cell tumor that is associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

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FDA Will Review Application Seeking Expansion of Keytruda’s Dosing Schedule https://melanomaresearchvic.com.au/fda-will-review-application-seeking-expansion-of-keytrudas-dosing-schedule Mon, 19 Aug 2019 22:00:23 +0000 https://melanomaresearchvic.com.au/?p=13804 The U.S. Food and Drug Administration (FDA) has accepted for review six supplemental biologics license applications (sBLAs) seeking to expand the dosing schedule of Keytruda (pembrolizumab) so the medication can be administered every six weeks.

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Source: Immuno-Oncology News, August 2019

The U.S. Food and Drug Administration (FDA) has accepted for review six supplemental biologics license applications (sBLAs) seeking to expand the dosing schedule of Keytruda (pembrolizumab) so the medication can be administered every six weeks.

Keytruda is a checkpoint blockade immunotherapy developed by Merck(known as MSD outside the U.S. and Canada), which has been approved by the FDA and the European Medicines Agency (EMA) for treating several types of cancer.

It is a monoclonal antibody that has been designed to target and block the activity of the PD-1 receptor (a protein found on the surface of immune cells), preventing cancer cells from avoiding being targeted and killed by immune cells.

read the original full article

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FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications https://melanomaresearchvic.com.au/fda-approval-sought-for-extended-pembrolizumab-dosing-schedule-for-select-indications Sun, 14 Jul 2019 22:00:48 +0000 https://melanomaresearchvic.com.au/?p=13585 Source: OncLive, July 2019 The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.1 The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical […]

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Source: OncLive, July 2019

The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.1 The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, and primary mediastinal large B-cell lymphoma.

For the sBLAs, the dosing schedule would be updated in the following indications:

 

read the original full article

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