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The drug received accelerated approval in October 2017 as monotherapy for adults with MCL who have received at least one prior treatment. The FDA simultaneously converted the conditional approval to full approval for this indication.

FDA Approves First BTK Inhibitor as First-Line Therapy for Mantle Cell Lymphoma

Here’s what you missed this week on Managed Healthcare Executive.

MHE Week in Review – WHO Withdrawal, Bird Flu Vaccine in Works

Carl Schmid, executive director of the HIV+Hepatitis Policy Institute in Washington, D.C., talks about the problems associated with generic HIV PrEP drug markups and potential ways to fix it. 

PBM Reform: The Challenges of PrEP Access 

This new generic medicine is designed to be a simple, once-daily treatment for children as young as three months old who weigh at least 13 pounds.

Lupin's Generic HIV Treatment for Children Receives Tentative FDA Approval

Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.

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Hub services are expanding functions to facilitating access to needed therapies or devices and addressing barriers to adherence.

Pharma’s Role in Addressing Social Determinants of Health

The FDA has approved Tevimbra (tislelizumab-jsgr) for a second indication: in combination with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express the protein PD-L1.

Gastric cancer, commonly known as stomach cancer, is the fifth most common cancer globally and the fifth leading cause of cancer-related deaths, according to a release by BeiGene, the developer of Tevimbra.

In 2022 alone, nearly 1 million new cases were diagnosed worldwide, and the disease claimed 660,000 lives.

According to the American Cancer Society, there is an estimated 27,000 people in the United States who were diagnosed with gastric cancer in 2024, leading to approximately 11,000 deaths. The number of new cases of stomach cancer in the United States has been dropping by about 1.5% each year over the last 10 years.

This latest approval is the second for Tevimbra in 2024, as the drug was previously 

 in the United States as a monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) in adults following prior systemic chemotherapy that excluded the PD-L1 inhibitor. 

Temimbra launched in October 2024 at a price that company officials 

 was  10% lower than other anti-PD-1 therapies approved in this indication. At the time of launch, the average wholesale acquisition cost of Tevimbra was about $15,075 per month, 

 that updated pricing will be available in a few weeks.

The recent approval for Tevimbra’s use in gastric cancers is based on data from BeiGene’s 

 that was designed to evaluate the efficacy and safety of the drug in combination with chemotherapy.

Data revealed that the overall survival was 15 months for patients treated with Tevimbra and chemotherapy, compared with 12.9 months for those receiving placebo and chemotherapy. The hazard ratio was 0.80,  indicating a 20% reduction in the risk of death.

To better understand the drug’s safety, researchers analyzed data from 1,972 patients. Significant side effects that occurred when the treatment was combined with chemotherapy included issues with patient’s blood such as low white blood cells, low platelets and low red blood cells.

Other common side effects were fatigue, lung infections such as pneumonia, loss of appetite, skin rashes, liver problems, diarrhea and lung inflammation through pneumonitis.

Gastric cancer, commonly known as stomach cancer, is the fifth most common cancer globally and the fifth leading cause of cancer-related deaths.

Clinical

Progress Made for Gastric Cancer with FDA Approval of Tevimbra 

The FDA approved Spravato (esketamine) CIII nasal spray today as a first-of-its-kind, standalone treatment for adults with major depressive disorder (MDD) who haven't responded well to at least two oral antidepressants.

MDD is one of the most common mental health disorders, affecting about 21 million adults in the U.S., according to a press release by Johnson & Johnson.

However, one-third of folks with the disorder experience treatment-resistant depression (TRD), a condition that makes it more difficult to be treated by traditional oral antidepressants.

This approval comes after a Priority Review, which indicates that the FDA sees this treatment as highly needed.

It is also based on results from a randomized, double-blind, multicenter, placebo-controlled study, where those who used Spravato alone showed faster and more significant improvements in their depression scores compared to those who took a placebo.

After 4 weeks, 22.5% of patients on Spravato achieved remission and received a much lower depression score, compared to just 7.6% of those on the placebo.

Bill Martin, Ph.D., global therapeutic area head at Johnson & Johnson, said in the release that patients who take Spravato may experience improvements in depressive symptoms as early as 24 hours and at 28 days — without the need for daily oral antidepressants.

The drug works by targeting glutamate, a common neurotransmitter in the brain. While the exact way it works is still not fully understood, studies have shown that it can help reduce depression symptoms quickly.

Spravato has been used for years in combination with other antidepressants, and over 140,000 patients worldwide have been treated with it.

A spokesperson from Johnson & Johnson explained that the cost of Spravato for patients depends on their insurance and how their healthcare plan is structured.

“We have worked hard to demonstrate the clinical value of Spravato which has helped drive strong access for patients, but again patients’ out-of-pocket costs are determined by insurance benefit design,” the spokesperson said.

They also noted that reimbursement for the two-hour monitoring period required during treatment depends on the specific agreement’s clinics have with insurance companies.

The spokesperson did not share the drug’s current market value, but according to the National Institutes of Health, it’s at a value of $18,564 to $45,591 in the first year and about $14,196 to $42,588 by the second and on.

Spravato has a safety profile that is similar with its previous use though there are some risks, including sedation, dissociation, respiratory depression and potential for misuse.

Because of these risks, Spravato is only available through a restricted program known as the Spravato Risk Evaluation and Mitigation Strategy (REMS) Program, which ensures it is used safely.

Gregory Mattingly, M.D., president of midwest research Group, said in the press release that “For more than six years, I've seen firsthand the real-world impact Spravato can have on patients' lives. Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs, so patients can experience the efficacy of Spravato in as little as 24 hours, through day 28, without the need for a daily oral antidepressant.”

While Spravato has already helped many with treatment-resistant depression, further research is suggested on its potential use in younger patients.

Depression among younger patients has been increasing, especially after the COVID-19 pandemic.

 by MHE, in 2021, nearly 20.1% of U.S. young adults aged 12 to 17 reported experiencing at least one major depressive episode.

Advocates are urging more studies to explore whether Spravato could help this younger group.

Although research is still ongoing regarding the drug’s use in younger patients, its potential to help adults with treatment-resistant depression is already a significant breakthrough.

One-third of folks with major depressive disorder experience treatment-resistant depression (TRD), a condition that makes it more difficult to be treated by traditional oral antidepressants.


FDA Approves Spravato Nasal Spray as a Standalone Treatment for Major Depressive Disorder

The U.S. FDA has granted tentative approval to global pharmaceutical company Lupin Limited for its generic version of Triumeq PD tablets for oral suspension, a treatment for pediatric HIV.

This approval brings the medication one step closer to making HIV treatment more affordable and accessible for children in low- and middle-income countries, according to a news release by Lupin.

The medication, which combines Abacavir, Dolutegravir and Lamivudine, will be produced at Lupin’s Nagpur facility in India.

According to the CDC, 1.37 million children are living with HIV, globally.

 tested over 3.5 million children and supported treatment for more than 300,000 children under 15 years old living with HIV.

Clinical trials have shown that the combination of Dolutegravir, Abacavir, and Lamivudine is effective in treating HIV.

In one study with 833 participants who had not received prior treatment, 88% of patients taking the higher dosage version of the Triumeq combination had undetectable levels of HIV after 48 weeks, compared to 81% in another treatment group.

The National Institutes of Health explained that HIV can pass from a birthing parent with HIV to their child during pregnancy, childbirth or breastfeeding. This process, called perinatal transmission of HIV, is the most common way children under 13 years old in the U.S. acquire HIV.

Additionally, HIV treatment in children is influenced by factors like growth and development. Since children grow at different rates, the dosage of HIV medicine often depends on a child’s weight rather than their age.

 are designed to meet these specific needs, helping manage HIV in children and reduce the risk of the virus being passed from mothers to babies during pregnancy or breastfeeding.

, the U.S. President’s Emergency Plan for AIDS Relief.

Since its launch in 2003, PEPFAR has invested over $100 billion in fighting HIV/AIDS globally. It has saved millions of lives and strengthened healthcare systems, particularly in low-income areas.

As PEPFAR keeps making a difference, the new generic version from Lupin is expected to lower the cost of HIV treatment, the release said.

By offering a lower-cost alternative, Lupin’s medicine could help many more children access the treatment they need.

While Lupin awaits full FDA approval, the potential impact of its generic Triumeq PD is clear and could change the lives of children with HIV and their families.

The FDA recently granted marketing authorization for the TriVerity Test System — a new molecular diagnostic test developed by Inflammatix.

This first-of-its-kind test provides a comprehensive assessment of patients with suspected acute infections or sepsis by measuring the body's immune response.

The TriVerity test offers clinicians a faster evaluation of infection type and severity, according to a news release.

Sepsis — a life-threatening condition caused by the body's response to infection — remains a significant challenge in healthcare.

According to the Mayo Clinc, as sepsis worsens, vital organs, such as the brain, heart and kidneys, don't get as much blood as they should.

Most can recover from mild sepsis, but the mortality rate for septic shock is about 30% to 40%.

Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix, said billions of dollars and decades of work have been invested in sepsis care.

“Sepsis mortality remains frustratingly high, and sepsis remains the most expensive diagnosis to the healthcare system,” Sweeney added.

One of the key issues with existing diagnostic methods is the outdated focus on labeling patients as “septic or not,” despite the complex and evolving nature of sepsis, he said.

To address this gap, TriVerity focuses on whether the patient has an infection and how severely ill they are likely to become.

The TriVerity test measures the expression levels of 29 genes associated with the immune response to infection.

It also uses artificial intelligence and machine learning to create three critical scores: how likely it is that the patient has a bacterial infection, how likely it is they have a viral infection and the risk of developing a severe illness that might need treatments such as a breathing machine or strong medications within the next week.

These insights give a detailed outlook of a patient’s condition, enabling healthcare providers to make timely decisions.

Emergency departments across the country face many challenges, including overcrowding and lengthy hospital stays. TriVerity aims to alleviate this burden by improving the triage process, the release said.

Currently, assessing if a patient has sepsis usually results in testing or examining up to 20 people for every confirmed case.

TriVerity focuses on whether the patient has an infection and how severely ill they are likely to become.

Maureen Hennessey, PhD, CPCC, CPHQ

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