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Rachel V Thomas

Tudriqev: US FDA Approves Replimune's Skin Cancer Drug After Rejecting It Twice

The US Food and Drug Administration (FDA) has granted accelerated approval to Replimune's Tudriqev for the treatment of advanced refractory melanoma—a deadly form of <a href="https://www.healthandme.com/health/skin-cancer">skin cancer</a> that continues to grow or spread despite treatment with standard immunotherapy drugs such as PD-1 inhibitors.

The approval comes after the FDA rejected the therapy twice over concerns related to the quality of clinical data.

The latest decision was supported by clinical trial results showing that 24% of patients responded to treatment, with responses lasting a median of 14.1 months. The FDA also considered input from clinical experts and patient advocates, who highlighted the urgent need for new treatment options for patients with refractory <a href="https://www.healthandme.com/health/melanoma">melanoma</a>.

Tudriqev is an oncolytic viral immunotherapy based on a genetically modified herpes simplex virus type 1 (HSV-1). The virus is engineered to selectively infect and destroy cancer cells while stimulating the body's immune system to recognize and attack the tumour.

The therapy is approved in combination with nivolumab for adults with unresectable melanoma that:

<ul><li>Has spread or cannot be safely removed through surgery.</li><li>Has progressed after treatment with a PD-1-blocking antibody-based regimen.</li></ul>

"For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited. Clinicians managing these patients know this urgency firsthand," said Karim Mikhail, Acting Director of the FDA's Center for Biologics Evaluation and Research (CBER).

Also read: <a href="https://www.healthandme.com/health-news/narcolepsy-us-fda-approves-first-ever-pill-that-targets-root-cause-of-rare-sleep-disorder-article-155357940" data-type="tilCustomLink">Narcolepsy: US FDA Approves First-Ever Pill That Targets Root Cause of Rare Sleep Disorder</a>

Tudriqev is injected directly into tumours, where the modified virus replicates inside cancer cells, causing them to rupture. At the same time, it activates the immune system to identify and attack cancer cells throughout the body.

When combined with nivolumab, an anti-PD-1 immunotherapy, Tudriqev may help restore an anti-tumour immune response in patients whose melanoma no longer responds to checkpoint inhibitor therapy.

Tudriqev is administered once every two weeks for eight consecutive doses.

<ul><li>The dose is determined by tumour size.</li><li>A lower concentration is used for the first injection, followed by a higher concentration for the remaining doses.</li><li>Nivolumab is administered intravenously starting in week three of treatment.</li></ul>

Replimune has announced a list price of $450,000 per course of therapy, before rebates and discounts.

The FDA based its approval on an open-label, multiregional, single-arm trial involving 140 adults with Stage IIIB, IIIC, or IV unresectable melanoma whose disease progressed after at least eight consecutive weeks of prior anti-PD-1 therapy.

<ul><li>24% achieved an objective response.</li><li>The median duration of response was 14.1 months.</li></ul>Read More: <a href="https://www.healthandme.com/health-news/us-issues-measles-alert-after-infected-visitor-spent-11-hours-at-universal-studios-hollywood-article-155354570" data-type="tilCustomLink">US Issues Measles Alert After Infected Visitor Spent 11 Hours at Universal Studios Hollywood</a>

A confirmatory Phase III study is currently underway to verify the drug's clinical benefit. Replimune expects results in 2030.

The most common side effects reported in more than 10% of patients included:

<ul><li>Fatigue</li><li>Fever (pyrexia)</li><li>Infections</li><li>Chills</li><li>Musculoskeletal pain</li><li>Nausea and Vomiting</li><li>Diarrhoea</li><li>Injection-site reactions</li><li>Headache</li><li>Cough</li><li>Influenza-like illness</li><li>Rash</li><li>Shortness of breath (dyspnoea)</li><li>Bleeding (haemorrhage)</li><li>Oedema</li><li>Abdominal pain</li></ul>

<ul><li>The risk of accidental transmission of herpes infection to close contacts.</li><li>Development or reactivation of herpes infection in treated patients.</li><li>Injection-related complications.</li></ul>

Melanoma is the deadliest form of skin cancer and the fifth most common cancer in the United States. An estimated 105,000 new cases are expected to be diagnosed in the US in 2025, with the disease causing nearly 8,500 deaths each year.

Immune checkpoint inhibitors are the current standard treatment for advanced melanoma, but about half of patients either do not respond or eventually develop resistance, underscoring the need for new treatment options such as Tudriqev.

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The US Food and Drug Administration (FDA) has granted accelerated approval to Replimune's Tudriqev for the treatment of advanced refractory melanoma—a deadly form of skin cancer that continues to grow or spread despite treatment with standard immunotherapy drugs such as PD-1 inhibitors.The approval comes after the FDA rejected the therapy twice over concerns related to the quality of clinical data.The latest decision was supported by clinical trial results showing that 24% of patients responded to treatment, with responses lasting a median of 14.1 months. The FDA also considered input from clinical experts and patient advocates, who highlighted the urgent need for new treatment options for patients with refractory melanoma.What Is Tudriqev?Tudriqev is an oncolytic viral immunotherapy based on a genetically modified herpes simplex virus type 1 (HSV-1). The virus is engineered to selectively infect and destroy cancer cells while stimulating the body's immune system to recognize and attack the tumour.The therapy is approved in combination with nivolumab for adults with unresectable melanoma that:Has spread or cannot be safely removed through surgery.Has progressed after treatment with a PD-1-blocking antibody-based regimen."For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited. Clinicians managing these patients know this urgency firsthand," said Karim Mikhail, Acting Director of the FDA's Center for Biologics Evaluation and Research (CBER).Also read: Narcolepsy: US FDA Approves First-Ever Pill That Targets Root Cause of Rare Sleep DisorderHow Does Tudriqev Work?Tudriqev is injected directly into tumours, where the modified virus replicates inside cancer cells, causing them to rupture. At the same time, it activates the immune system to identify and attack cancer cells throughout the body.When combined with nivolumab, an anti-PD-1 immunotherapy, Tudriqev may help restore an anti-tumour immune response in patients whose melanoma no longer responds to checkpoint inhibitor therapy.How Is The Treatment Given?Tudriqev is administered once every two weeks for eight consecutive doses.The dose is determined by tumour size.A lower concentration is used for the first injection, followed by a higher concentration for the remaining doses.Nivolumab is administered intravenously starting in week three of treatment.Replimune has announced a list price of $450,000 per course of therapy, before rebates and discounts.Clinical trial resultsThe FDA based its approval on an open-label, multiregional, single-arm trial involving 140 adults with Stage IIIB, IIIC, or IV unresectable melanoma whose disease progressed after at least eight consecutive weeks of prior anti-PD-1 therapy.Among the 91 evaluable patients:24% achieved an objective response.The median duration of response was 14.1 months.Read More: US Issues Measles Alert After Infected Visitor Spent 11 Hours at Universal Studios HollywoodA confirmatory Phase III study is currently underway to verify the drug's clinical benefit. Replimune expects results in 2030.Safety and Side EffectsThe most common side effects reported in more than 10% of patients included:FatigueFever (pyrexia)InfectionsChillsMusculoskeletal painNausea and VomitingDiarrhoeaInjection-site reactionsHeadacheCoughInfluenza-like illnessRashShortness of breath (dyspnoea)Bleeding (haemorrhage)OedemaAbdominal painThe FDA also warned of:The risk of accidental transmission of herpes infection to close contacts.Development or reactivation of herpes infection in treated patients.Injection-related complications.About melanomaMelanoma is the deadliest form of skin cancer and the fifth most common cancer in the United States. An estimated 105,000 new cases are expected to be diagnosed in the US in 2025, with the disease causing nearly 8,500 deaths each year.Immune checkpoint inhibitors are the current standard treatment for advanced melanoma, but about half of patients either do not respond or eventually develop resistance, underscoring the need for new treatment options such as Tudriqev.

tudriqev: us fda approves replimune's skin cancer drug after rejecting it twice

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