Specialised Therapeutics, Orlando, FL (2026)

05/04/2026

Following our recent MINJUVI® (tafasitamab) announcement, Specialised Therapeutics (ST) is pleased to announce that NIKTIMVO™ (axatilimab) has been approved in Australia for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and paediatric patients 6 years and older weighing at least 40 kg.

This approval marks another important step in expanding treatment options for patients across our growing haematology portfolio in Australia.

Axatilimab is a monoclonal antibody designed to target CSF-1R, a receptor involved in the pathways that drive inflammation and fibrosis in cGVHD.

𝐏𝐁𝐒 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧: This product is not available on the Pharmaceutical Benefits Scheme (PBS).

𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐬𝐚𝐟𝐞𝐭𝐲 𝐢𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧: NIKTIMVO has risks and benefits. The most commonly reported adverse reactions include fatigue, elevated liver enzymes and infusion-related reactions. Serious adverse reactions may occur.

▼ This medicine is included in the TGA Black Triangle Scheme. Please report suspected adverse events to the TGA.

For further information, including the approved Product Information and Consumer Medicine Information, please contact the ST Medical Information team at medicalenquiries@stbiopharma.com.

Click here to read the full Press Release: https://shorturl.at/ndhrD

04/23/2026

Specialised Therapeutics (ST) is pleased to announce that MINJUVI (tafasitamab) in combination with rituximab and lenalidomide (R2) has been approved in Australia for the treatment of adult patients with relapsed or refractory follicular lymphoma (Grade 1-3a).

Tafasitamab is a humanised anti-CD19 monoclonal antibody designed to target CD19-expressing B cells.

PBS Information: This product is not available on the Pharmaceutical Benefits Scheme (PBS).

Important safety information: MINJUVI has risks and benefits. The most commonly reported adverse reactions include infections, neutropenia, anaemia, thrombocytopenia, diarrhoea, cough, pyrexia and fatigue. Serious adverse reactions may occur.

Treatment decisions should be made in consultation with a healthcare professional.

For further information on the medicine, please refer to the Consumer Medicine Information (CMI): https://lnkd.in/gpkQY5uD

Click here to read the full Press Release: https://lnkd.in/gAn_qx8u

04/21/2026

Specialised Therapeutics (ST) is pleased to announce that ZEPZELCA®(lurbinectedin), in combination with atezolizumab, has been approved in Australia and Singapore for the maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐬𝐚𝐟𝐞𝐭𝐲 𝐢𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧: ZEPZELCA has risks and benefits. The most common adverse reactions (≥ 30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab in the clinical study were decreased lymphocytes, decreased platelets, decreased haemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue/asthenia.

Treatment decisions should be made in consultation with a healthcare professional.

For further information, including the approved Product Information and Consumer Medicine Information (CMI), please contact the ST Medical Information team at medicalenquiries@stbiopharma.com.

Click here to read the full Press Release: https://lnkd.in/gCcAUi2a

03/30/2026

𝗟𝗮𝘀𝘁 𝘄𝗲𝗲𝗸𝗲𝗻𝗱, 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝗲𝗱 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 𝘄𝗮𝘀 𝗽𝗿𝗼𝘂𝗱 𝘁𝗼 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝘁𝗵𝗲 𝗟𝘆𝗺𝗽𝗵𝗼𝗺𝗮 𝗔𝘂𝘀𝘁𝗿𝗮𝗹𝗶𝗮 𝗛𝗲𝗮𝗹𝘁𝗵 𝗣𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟲 𝗶𝗻 𝗦𝘆𝗱𝗻𝗲𝘆.

It was a valuable opportunity for our team to connect with nurses, allied health professionals and multidisciplinary healthcare teams from across Australia who are dedicated to improving outcomes for patients affected by lymphoma.

At Specialised Therapeutics, we remain committed to supporting the haematology community through our growing portfolio and our ongoing work to bring innovative therapies to patients across Australia and the Asia-Pacific region.

Thank you to the organisers and healthcare professionals whose work continues to make a meaningful difference for patients and their families.

12/09/2025

𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝗲𝗱 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 𝗶𝘀 𝗰𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗱 𝘁𝗼 𝗮𝗱𝘃𝗮𝗻𝗰𝗶𝗻𝗴 𝗵𝗮𝗲𝗺𝗮𝘁𝗼𝗹𝗼𝗴𝘆 𝗯𝘆 𝗯𝗿𝗶𝗻𝗴𝗶𝗻𝗴 𝗽𝗶𝘃𝗼𝘁𝗮𝗹 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝘁𝗼 𝘁𝗵𝗲 𝗴𝗹𝗼𝗯𝗮𝗹 𝘀𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆.

This year marks a significant period for Specialised Therapeutics, reinforcing our strategic collaboration with Incyte and enabling impactful, clinically relevant dialogue among experts through the presentation of tafasitamab and axatilimab updates.

𝗞𝗲𝘆 𝗔𝗦𝗛 𝗵𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗲:

𝗧𝗮𝗳𝗮𝘀𝗶𝘁𝗮𝗺𝗮𝗯 – 𝗶𝗻𝗠𝗜𝗡𝗗 𝘀𝘂𝗯𝗴𝗿𝗼𝘂𝗽 𝗮𝗻𝗮𝗹𝘆𝘀𝗲𝘀
• Outcomes by age – Publication 3582
• Outcomes in second-line treatment – Publication 1819
• Preservation of CD19 expression – Publication 5515
• Outcomes in high-risk patients – Publication 5367

𝗔𝘅𝗮𝘁𝗶𝗹𝗶𝗺𝗮𝗯 – 𝗔𝗚𝗔𝗩𝗘 𝟮𝟬𝟭 & 𝗿𝗲𝗹𝗮𝘁𝗲𝗱 𝘀𝘁𝘂𝗱𝗶𝗲𝘀
• Long-term treatment duration & safety – Publication 6010
• Expanded Access Program safety a**lysis – Publication 6008
• Combination with ruxolitinib in newly diagnosed chronic graft-versus-host disease – Publication 6012

2025 has offered opportunities to engage across major international meetings, including , , and . As we look to 2026, we remain committed to supporting clinicians with timely, evidence-based updates for rare cancers and rare diseases.

cGVHD RareCancers SpecialisedTherapeutics

12/06/2025

Follicular lymphoma may be classified as an indolent disease, but our drive to bring access to innovative treatment stays strong and purposeful.

At , our CEO, Medical Lead, and Therapeutic Lead are on the ground, connecting with haematologists and global experts to review emerging data and discuss evolving treatment approaches. Highlights this year include subgroup a**lyses from the inMIND study of tafasitamab and long-term results for axatilimab from AGAVE-201.

New evidence being presented at ASH may shape future clinical practice in follicular lymphoma and chronic graft-versus-host disease, and we’re committed to advancing therapies for rare and complex haematologic conditions.

11/27/2025

It was great to be back at , connecting with clinicians, researchers, and industry partners to advance care for patients with gastrointestinal (GI) cancers across Australia and New Zealand.

We had the opportunity to discuss evolving treatment strategies and translational research, keeping patients at the centre of our conversations.

Specialised Therapeutics continues to grow our GI oncology portfolio, now including retifanlimab (squamous cell a**l cancer) alongside Abraxane® (nab-paclitaxel – pancreatic and GI cancers), Pemazyre® (pemigatinib – cholangiocarcinoma), Qinlock® (ripretinib – gastrointestinal stromal tumours), and Yondelis® (trabectedin – soft tissue sarcomas), reflecting our commitment to supporting healthcare professionals in delivering patient-focused care.

marked our final oncology conference for 2025, reinforcing our dedication to collaboration, scientific exchange, and improving outcomes for patients.

AdvancingCancerCare

11/25/2025

𝗧𝗵𝗲 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝗲𝗱 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 𝘁𝗲𝗮𝗺 𝗶𝘀 𝗮𝘁 𝗔𝗚𝗜𝗧𝗚 𝟮𝟬𝟮𝟱!

We’re onsite at the GI Cancer Trials (formerly AGITG) Annual Scientific Meeting 2025, connecting with clinicians, researchers, and industry partners to advance care for patients living with gastrointestinal (GI) cancers.

If you’re attending, come say hello and speak with our team about evolving treatment approaches and our expanding GI oncology portfolio.

09/10/2025

The Consumer Comments process invites patients, carers, healthcare professionals, and advocacy groups to share their experiences, helping inform decisions that affect access to life-changing treatments.

Your input can help ensure that decisions reflect what matters most to those affected. Early engagement is key to shaping outcomes that truly make a difference and impact funding decisions.

This is a unique opportunity: four indications from our pipeline are being reviewed simultaneously, giving stakeholders a chance to provide input on multiple treatments at once.

Reimbursement for therapies in the following disease areas will be under consideration by the Pharmaceutical Benefits Advisory Committee (PBAC) at its November 2025 meeting:

• First-Line Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
• Metastatic Squamous Cell Carcinoma of the A**l Ca**l (SCAC)
• Locally Advanced or Metastatic Merkel Cell Carcinoma (MCC)
• Relapsed/Refractory Follicular Lymphoma (R/R FL)

👉 Submit your comment here: https://2cm.es/19ha2

**lCancer

09/07/2025

สวัสดีค่ะ from Bangkok!

Recently, our team at Specialised Therapeutics attended the 18th Breast Cancer Symposium in .

This annual scientific meeting, themed “Practice Changing in Breast Cancer Management,” welcomed around 200 clinicians and international experts to discuss the latest developments in care.

Over three days, our team connected with more than 100 surgeons and specialists, contributing to discussions on evolving treatment strategies and sharing updates from our breast cancer portfolio, while gaining valuable insights into local clinical practice and patient needs.

Our participation reflects Specialised Therapeutics’ growing presence in and our continued commitment to working alongside healthcare professionals to help address unmet needs in oncology.

ขอบคุณค่ะ 🙏 to the organisers and all the clinicians who welcomed us at this important meeting.

Specialised Therapeutics

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