Latest news with #Ivosidenib
Time of India
4 days ago
- Health
- Time of India
Acute Myeloid Leukemia: From fatigue to fever, the subtle symptoms to know
It often starts with something as ordinary as tiredness. A lingering fever. Bruises that weren't there yesterday, for many, these signs don't ring alarm bells- until they do. June is observed as AML Awareness Month, A crucial time to talk about acute myeloid leukaemia (AML)- a type of blood cancer that can advance rapidly if ignored. Despite being aggressive, AML doesn't always begin with dramatic symptoms. Some of the earlier signs are subtle, everyday experiences that we often tend to overlook, such as fatigue, fever, minor infections, or even pale skin. But when these persist, it's time to look deeper. What exactly is AML? AML affects the body and bone marrow, leading to the production of abnormal white blood cells that crowd out healthy ones. In simple terms, the body's defence system is compromised from the inside. Dr Sameer Melinkeri, Hemato-oncologist and Director of Bone Marrow Transplant at Sahyadri Hospital, Pune, explains, 'AML symptoms mimic common conditions fever, fatigue, frequent infections, or bruising. Unfortunately, these signs are often dismissed or treated symptomatically, leading to late-stage detection.' Key symptoms include: Persistent fatigue or Weakness Unexplained fever or night sweats Frequent or severe infections Easy bruising or bleeding Pale skin (anaemia) Bone pain Diagnosis and challenges Diagnosis typically begins with a complete blood count, followed by a bone marrow biopsy. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like What Does My Family Name Mean? beenverified Sign Up Undo Additional genetic and molecular testing helps determine the exact subtype and suitable treatment. In India, where fevers are commonly attributed to viral infections like dengue or typhoid, AML is often missed until it progresses, especially in primary healthcare settings. According to estimates from the Indian Council of Medical Research, blood cancers make up around 8-10% of total cancer cases in the country, and AML is a major contributor among adults. Is treatment possible? Yes, but it's not simple. The treatment is costly, says Dr Melinkeri. 'Earlier, AML was treated only with intensive chemotherapy or Bone Marrow Transplant. However, not all individuals, particularly elderly patients, can't manage that intensity of treatment. Only about half the patients can complete the full course due to financial barriers. With the advent targeted therapies such as Ivosidenib, Azacitidine and Venetoclax, individual mutations in AML could be targeted leading do minimal collateral damage to normal blood cells. ' Why does awareness matter more than ever? In a country like ours, a lack of awareness is one of the biggest enemies. People ignore symptoms until it's too late, not because they don't care, but because they don't know what to look for. That is why this June, AML Awareness Month becomes more than just a calendar note. It's a reminder to listen to our body talk to a doctor if something feels off. Even if it is just fatigue. AML might be rare, but when it strikes, it doesn't wait and neither should we.
Time of India
25-06-2025
- Health
- Time of India
Hope for AML patients with rare gene mutation
Pune: New and emerging therapies, which cause less collateral damage to normal blood and target specific mutations, are a promising alternative to treat Acute Myeloid Leukemia (AML), several oncologists have said. June is AML awareness month. Specialists have begun using ivosidenib, one such drug, that targets AML with IDH mutation, after Central Drugs Standard Control Organisation approved it in May. You Can Also Check: Pune AQI | Weather in Pune | Bank Holidays in Pune | Public Holidays in Pune India accounts for the highest number of AML cases after the US and China as per statistics from 2021. Dr Sameer Melinkeri, clinical haematologist at Pune's Deenanath Mangeshkar Hospital & Research Centre, said new therapies such as ivosidenib, azacitidine and venetoclax, help precisely target individual mutations in AML. "Ivosidenib is the first targeted therapy developed specifically for AML patients who carry the rare IDH1 gene mutation," said Dr Melinkeri. "It blocks a faulty enzyme—mutant IDH1—that causes the buildup of a harmful substance called 2-hydroxyglutarate in the body. This substance stops blood cells from maturing and spreads cancer cells," the doctor added. He said ivosidenib turns off the cancer-causing switch (mutation) in patients with IDH, a specific gene mutation. By stopping the enzyme, ivosidenib helps blood cells mature normally, reducing cancerous cells and allowing healthy cells to grow. Dr Reshma Puranik, a medical and haemato-oncologist with MOC, Cancer Care and Research Centre said that ivosidenib is a first-in-class, oral, small-molecule inhibitor of the mutant IDH1 enzyme and works well in brain tumors with IDH mutation. In trials, ivosidenib and azacitidine achieved superior outcomes with similar toxicity compared to azacitidine with newly-diagnosed IDH1-mutated AML. "Patients on ivosidenib need to monitor blood counts along with renal and liver function tests, serum electrolytes and QT interval on ECG. Some patients get a minor rash, feel fatigued, have oral mucositis (ulcers) and are at risk of differentiation syndrome," Dr Puranik added. While the new targeted therapies are expensive, more awareness and distributors in the market will bring the cost down, experts say. Dr Shilpa Gupta, consultant haemato-oncologist in a Mumbai-based cancer centre, said, "I have started ivosidenib for a patient and will wait for the results."
India.com
22-06-2025
- Health
- India.com
Acute Myeloid Leukemia: Expert Explains Why This Aggressive Blood Cancer Is Rising Fast In India
AML Awareness Month is marked each June. In India, where infectious diseases dominate public health narratives, a quieter and deadlier crisis is unfolding- Acute Myeloid Leukemia (AML). About 10-15% of all leukaemia cases, AML is a rapidly progressing blood cancer that requires immediate intensive treatment. Yet, delayed diagnosis and poor access to specialised care are making outcomes grim for hundreds of Indians each year. Who is at Risk? Dr Ashay Karpe, Consultant Haematologist and Bone Marrow Transplant Physician, SUNACT Cancer Institute, Mumbai, says, "AML is a cancer of blood and bone marrow that advances quickly, leading to an overproduction of immature white blood cells. While globally it is often diagnosed in the elderly, Indian patients tend to be younger, with many cases presenting in people in their 30s and 40s." According to data from the National Cancer Registry Programme (NCRP), the incidence of AML in India is estimated to be between 0.8 and 5 per 100,000 population. Where and Why Does Diagnosis Lag? In the early stages, AML is a master of disguise. Persistent tiredness, low-grade fever, or frequent bruising are often brushed off as minor or seasonal issues by patients and frontline doctors alike. This tendency, particularly in smaller towns and rural belts, allows the disease to progress unchecked. "AML doesn't give you much time," says Dr Ashay. "By the time a patient sees a specialist, they have often already lost critical ground. Early intervention is the difference between life and loss.' Unfortunately, the early intervention depends on access, and access is so far from equitable. From Chemo to Targeted Therapy Standard AML Therapy isn't just intensive- it's expensive. But the treatment landscape is evolving. Recent advancements in AML treatment like Venetoclax and targeted therapies such as Ivosidenib, are helping clinicians treat patients more effectively, especially those with specific genetic mutations. The arrival of Ivosidenib brings a ray of hope for those with the IDH1 mutation. These drugs are changing the paradigm of AML care, offering new hope where conventional therapy might fail or be too risky for elderly or frail patients. What can change the Odds? Dr Karpe, a leading haematologist, warns: 'In India, without expert guidance at diagnosis, we are already several steps behind global standards. Early bone marrow biopsy and cytogenetic profiling are not luxuries-they are lifesavers.' He underscores that proper counselling and early referral improve survival by allowing timely intensive chemotherapy and transplant planning. 'Patients arrive late, often battling infections for organ failure, says Dr Karpe. In AML, that delay is often irreversible.' Dr Karpe highlights the need to focus on basic upgrades: 1. Training general practitioners to spot danger signs early 2. Ensuring bone marrow testing facilities in public hospitals 3. Including newer targeted drugs and diagnostics as part of the national care He adds, 'A simple CBC (Complete Blood Count) can be the first clue, but someone has to ask for it at the right time. This is why it matters Now." AML might not affect millions, but every case is a race against the clock. In a nation with a rapidly shifting disease landscape, early diagnosis, fast-track specialist care, and policy-level intervention could stop this disease from becoming a death sentence. India has tools. What it needs now is urgency.
United News of India
11-06-2025
- Health
- United News of India
Servier India launches ‘Ivosidenib' Tibsovo
Kochi, Jun 10 (UNI) Servier India, a subsidiary of the leading French pharmaceutical Servier Group, has announced the launch of Ivosidenib (Tibsovo®), an oral targeted therapy approved in the management of cancer patients with Acute Myeloid Leukemia (AML) and Cholangiocarcinoma, with an isocitrate dehydrogenase-1 (IDH1) mutation. Servier India received the approval on 14th May 2025, from Central Drugs Standard Control Organisation (CDSCO) for the import, sale, and distribution of the medication. Acute myeloid leukemia is a challenging hematological malignancy. Studies indicate that only about 30–40 percent of AML patients in India receive adequate treatment, with high mortality rates due to rapid disease progression and infections. Cholangiocarcinomas (CCA) are rare tumours originating from the bile duct. Due to their asymptomatic nature, they are usually diagnosed when the disease is advanced. The announcement marks a significant advancement in the management of the mentioned rare and difficult-to-treat cancers in India, addressing a critical unmet medical need. Aurélien Breton, Managing Director, Servier India, said, 'Our focus is to advance oncology care by bringing innovative, precision medicines to patients who need them the most." "By prioritizing access and working to make treatment options affordable to patients, we are dedicated to bridging critical gaps in cancer care across the country. This launch will support healthcare providers with targeted treatment options and ultimately improve survival outcomes and quality of life for patients throughout India.' IDH1 mutation occurs in approximately 7–14 percent of AML patients in India, making targeted mechanisms especially relevant for this subset. 'This therapy represents a significant therapeutic option in the treatment of AML and Cholangiocarcinoma. For healthcare professionals, this precision therapy offers a new, effective option that can improve patient outcomes where traditional treatments have limited success. It highlights the benefits of targeted therapy and caliber of innovation in enhancing lives and advancing cancer care in India.', highlighted Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India. By introducing these advanced therapies, Servier India reaffirms its commitment to advancing innovative cancer treatments that improve clinical outcomes and enhance the quality of life of patient. UNI DS BD
Business Standard
05-06-2025
- Health
- Business Standard
Servier India introduces 'Ivosidenib'(Tibsovo®), in India, First-in-class Targeted Therapy in Oncology for Rare IDH1-Mutated AML and Cholangiocarcinoma
VMPL Mumbai (Maharashtra) [India], June 5: Servier India, a subsidiary of the leading French pharmaceutical Servier Group, today announced the launch of Ivosidenib (Tibsovo®), an oral targeted therapy approved in the management of cancer patients with Acute Myeloid Leukemia (AML) and Cholangiocarcinoma, with an isocitrate dehydrogenase-1 (IDH1) mutation. Servier India received the approval on 14th May 2025, from Central Drugs Standard Control Organisation (CDSCO) for the import, sale, and distribution of the medication. Acute myeloid leukemia is a challenging hematological malignancy. Studies indicate that only about 30-40% of AML patients in India receive adequate treatment1, with high mortality rates due to rapid disease progression and infections. Cholangiocarcinomas (CCA) are rare tumours originating from bile duct. Due to their asymptomatic nature they are usually diagnosed when the disease is advanced.2 The announcement marks a significant advancement in management of the mentioned rare and difficult-to-treat cancers in India, addressing a critical unmet medical need. Speaking on the occasion, Mr. Aurelien Breton, Managing Director, Servier India, said, "Our focus is to advance oncology care by bringing innovative, precision medicines to patients who need them the most. By prioritizing access and working to make treatment options affordable to patients, we are dedicated to bridging critical gaps in cancer care across the country. This launch is a significant step forward in our mission to support healthcare providers with targeted treatment options and ultimately improve survival outcomes and quality of life for patients throughout India." IDH1 mutation occurs in approximately 7-14% of AML patients in India3, making targeted mechanisms especially relevant for this subset. "This therapy represents a significant therapeutic option in the treatment of AML and Cholangiocarcinoma. For healthcare professionals, this precision therapy offers a new, effective option that can improve patient outcomes where traditional treatments have limited success. It highlights the benefits of targeted therapy and caliber of innovation in enhancing lives and advancing cancer care in India.", highlighted Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India. Speaking on the importance of treatment access, Ms. Pratima Tripathi, Commercial Director, Servier India, said: "Our foremost priority is to ensure that the therapy is accessible and affordable to patients across India. We are actively collaborating with healthcare providers, patient advocacy groups, and policymakers to remove barriers and facilitate timely access to this important therapy. Through these partnerships, we are committed to expanding treatment options and making a meaningful difference in the lives of patients." By introducing these advanced therapies, Servier India reaffirms its commitment to advancing innovative cancer treatments that improve clinical outcomes and enhance the quality of life of patients. Disclaimer: This press release is intended solely to share regulatory and medical information regarding the launch; the reference to "Tibsovo" is not intended as a promotional or public advertisement. Use of the therapy is strictly based on a doctor's prescription and clinical discretion. About Servier India Servier India has been committed for over three decades to delivering innovative pharmaceutical solutions that improve the lives of patients and their families across India. Established in 1985 as an affiliate of the leading independent French pharmaceutical Servier Group, the company focuses on therapeutic areas such as Cardiometabolism, Neuroscience, Venous Diseases, and Oncology. Servier India has a strong pan-India presence and a dedicated workforce of around 580 that strives to address critical healthcare challenges with passion and purpose. As part of Servier group operating in over 150 countries, Servier India inherits a rich legacy of scientific excellence and patient-centric innovation. Globally, Servier invests heavily in research and development, focusing on our key therapeutic areas. About Servier Servier is a global pharmaceutical group governed by a Foundation that aspires to serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. As a world leader in cardiometabolism and venous diseases, Servier's ambition is to become a focused and innovative player in oncology by targeting rare cancers. Headquartered in France, Servier relies on a strong geographical footprint; its medicines are available in close to 140 group achieved a revenue of EUR5.9 billion in 2024. Additional Details on Ivosidenib Internationally, Ivosidenib has already received regulatory approvals in more than 42 countries, including the USA, Europe, China, UAE, and South Korea. In the United States, the US FDA approved it in 2019 as a monotherapy and later in May 2022 as a combination treatment with Azacitidine for patients aged 75 and above, or those who cannot tolerate intensive chemotherapy. The European Medical Agency (EMA) gave its approval in May 2023 for use in patients who are not fit for standard induction chemotherapy. In India, the process moved forward in April 2025, when the Subject Expert Committee (SEC) gave a positive recommendation for Ivosidenib. Following this, the DCGI granted approval for the marketing authorization in May 2025
