On December 22, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of unresectable thymic carcinoma. Tecentriq received orphan drug designation for this indication from the MHLW on March 31, 2025. Chugai subsequently filed an application on May 14, 2025, which underwent Priority Review.

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"We are very pleased to be able to deliver Tecentriq as a new treatment option for unresectable thymic carcinoma. Effective treatment options for this disease are limited, and new therapies have been highly anticipated. We will continue our efforts to provide information on the proper use of Tecentriq to contribute to the patients with thymic carcinoma." said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results from the investigator-initiated phase II MARBLE study conducted in Japan, which evaluated the efficacy and safety of Tecentriq in combination with carboplatin and paclitaxel as first-line treatment for patients with unresectable thymic carcinoma.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

Approval Information *Excerpt from related parts

Indication: Unresectable thymic carcinoma
Dosage and administration:
All indications: The initial dose of Tecentriq must be administered over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be administered over 30 minutes.
Unresectable thymic carcinoma: The usual adult dosage is 1200 mg atezolizumab (genetical recombination) in combination with carboplatin and paclitaxel by intravenous infusion once every 3 weeks.

[Reference]
Chugai Files for Additional Indication of Tecentriq for the Treatment of Thymic Carcinoma
(Press release by Chugai issued on May 14, 2025)
View Source

About MARBLE study1
MARBLE study (jRCT2031220144) is a Japanese Phase II, multicenter, open-label, single-arm study led by investigators to evaluate the efficacy and safety of Tecentriq in combination with carboplatin and paclitaxel in patients aged 20 years or older with unresectable or advanced recurrent thymic carcinoma. The study evaluated safety and efficacy in 48 patients. The primary endpoint was overall response rate, and secondary endpoints included progression-free survival, overall survival, and safety.

About thymic carcinoma
Thymic carcinoma is a type of thymic epithelial tumor that originates from the thymic epithelium, which plays an important role in T-lymphocyte maturation, and is characterized by cellular atypia. The annual incidence in Japan is estimated to be 0.29 per 100,000 people2. The prognosis for unresectable cases is poor, highlighting the need for new therapeutic options.

About Tecentriq
Tecentriq is a cancer immune checkpoint inhibitor targeting PD-L1, which is a protein expressed on tumor and tumor-infiltrating immune cells. PD-L1 blocks T cell activity by binding with PD-1 and B7.1 receptors on the T cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T cells and boost immune response against cancer cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 6 tumour types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, and extranodal NK/T-cell lymphoma, nasal type).

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, DEC 22, 2025, View Source;category= [SID1234661587])

On December 22, 2025 AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, reported, that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, Jan. 14, 2026. The Company’s presentation will begin at 3:00 p.m. (PT).

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A live webcast of the event will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

(Press release, AngioDynamics, DEC 22, 2025, View Source [SID1234661603])

On December 22, 2025 Merck, a leading science and technology company, reported that following Priority Review, the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively severe morbidity. Pimicotinib, a colony stimulating factor-1 receptor (CSF-1R) inhibitor developed by Abbisko Therapeutics Co., Ltd., Shanghai, China, is the first Chemical Drug Class 1 approved in China for the treatment of TGCT.

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"We are continuing to deliver on our commitment to improving the lives of patients with rare tumors with this first-in-the-world regulatory approval of pimicotinib," said Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board of Merck. "This approval is a significant step forward in further strengthening our leadership in rare tumors, while offering patients the opportunity to change the course of their disease and help alleviate symptoms that impact their daily lives. We are now working to make pimicotinib available to patients in China as quickly as possible, as we continue to progress applications with regulatory authorities in additional markets."

TGCT is a rare, locally aggressive tumor of the joint leading to progressive swelling, stiffness and reduced mobility of the affected joint, significantly impacting daily activities and quality of life in the otherwise healthy population that it affects. If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. Historically TGCT may have been known by several different names, including pigmented villonodular synovitis (PVNS).

The approval of pimicotinib by the China NMPA is based on results from the global Phase 3 MANEUVER study, in which pimicotinib demonstrated the highest objective response rate (ORR) based on RECIST v1.1 seen in a Phase 3 trial of a systemic TGCT treatment, as well as meaningful improvements in clinical outcomes. At week 25, pimicotinib demonstrated a statistically significant improvement in the primary endpoint of ORR assessed by blinded independent review committee (BIRC) based on RECIST v1.1 compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). Pimicotinib also demonstrated clinically meaningful and statistically significant improvements across secondary endpoints relevant to patients’ daily lives, improving relative range of motion (p=0.0003) and physical function measured by PROMIS-PF scale (p=0.0074) and reducing worst stiffness (p<0.0001) and worst pain (p<0.0001). These findings were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. Longer-term results presented at the ESMO (Free ESMO Whitepaper) Congress 2025 showed that with a median follow-up of 14.3 months, ORR per RECIST v1.1 increased considerably among patients treated with pimicotinib from the beginning of the study, to 76.2% (95% CI: 63.8, 86.0).

"Many people living with TGCT in China have faced a long and difficult journey due to the lack of approved options beyond surgery, which may not address the needs of patients whose tumors recur or are not amenable to resection," said Prof. Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. "With the approval of pimicotinib based on the results of the global MANEUVER study, healthcare professionals in China will soon have the opportunity to prescribe their patients an effective and well-tolerated systemic treatment option, offering a much-needed advance in how they manage this challenging condition."

In MANEUVER, pimicotinib was well-tolerated, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. During the randomized, double-blind treatment phase of the trial, treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients.

"Pain and restricted mobility induced by TGCT impair patients’ daily functioning and impose huge psychological burden on them," commented Kevin Huang, Founder and President of Chinese Organization for Rare Disorders (CORD), and Founder and Secretary-General of the Hope For Rare Foundation. "Following the approval of pimicotinib in China, this systemic therapeutic regimen enables effective control of tumor progression and alleviation of clinical symptoms, bringing hope for patients who may regain the ability to join in activities deemed common by the most, such as climbing stairs, commuting to work, or playing with their children."

About MANEUVER

The pivotal global Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21).

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint was objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in the intent-to-treat (ITT) population. Secondary endpoints include ORR per tumor volume score (TVS), relative range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS-PF).

After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of further treatment. Patients who completed Part 2 could then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About pimicotinib (ABSK021)

Pimicotinib, developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. It has been granted breakthrough therapy designation (BTD) for the treatment of inoperable TGCT by the U.S. Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib.

(Press release, Merck KGaA, DEC 22, 2025, View Source [SID1234661588])

On December 22, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported it will be commencing a pivotal Phase III registrational trial of its 64Cu-SARTATE diagnostic agent in patients with neuroendocrine tumours (NETs). This follows a successful End of Phase meeting with the United States (US) Food and Drug Administration (FDA), in which all key components of the proposed trial design were agreed upon with the Agency. Recruitment into the trial is expected to commence in 2026.

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The trial will be a multi-centre, single arm, non-randomised, open-label Phase III diagnostic clinical trial of 64Cu-SARTATE Positron Emission Tomography (PET) in approximately 70 participants. As a pivotal trial, the final study results are intended to support an application to the US FDA for approval of 64Cu-SARTATE as a new diagnostic imaging agent in NETs.

The aim of this registrational trial is to investigate the ability of 64Cu-SARTATE PET/computed tomography (CT) to detect NETs, building on compelling preclinical and clinical trial data generated to date, including the first-in-human CL01 trial1 and the Phase II DISCO trial (NCT04438304)2-3. The DISCO trial findings were recently accepted for presentation at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium, which will be held January 8-10, 2026 (San Francisco, CA)4.

In the DISCO trial, 64Cu-SARTATE was found to be safe and well tolerated with lesion detection substantially higher than that of the current standard-of-care (SOC), 68Ga-DOTATATE. 64Cu-SARTATE also showed enhanced lesion detection in the liver, the most common metastatic site for patients with gastroenteropancreatic (GEP)-NETs. Hepatic metastatic burden is clinically important as it is strongly associated with patient outcomes and significantly influences clinical management of the disease5. The enhanced diagnostic capabilities of 64Cu-SARTATE offer significant potential to transform and advance both the detection and management of patients with NETs, paving the way for improved patient outcomes and more effective treatment pathways.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited to progress to a Phase III trial in the NETs indication and are thankful for the time and valuable guidance the FDA has provided on our 64Cu-SARTATE agent during the End of Phase meeting. This will be our third registrational trial, highlighting Clarity’s strong commitment to advancing our pipeline in areas of high unmet medical need with our next-generation Targeted Copper Theranostic products.

"Our team and collaborators are determined to progress 64Cu-SARTATE through this registrational trial and towards commercialisation as we continue building on excellent preclinical and clinical data clearly illustrating the advantages of this product over SOC agents. Time and time again we have shown our commitment to the highest standards of scientific and clinical research, putting ourselves head-to-head against the current SOC to clearly emphasise the benefits and enhanced diagnostic performance of our products, something that very few radiopharmaceutical companies do.

"We would like to thank everyone who contributed to progressing 64Cu-SARTATE to this exciting stage, from our patients who participate in our clinical trials and their families, to our incredible team, investigators and collaborators who work tirelessly towards our mutual goal of improving treatment outcomes for people with cancer. We also thank the FDA for their collaborative approach to our interactions, which we have now experienced for many years. We believe that better diagnostic tools will help clinicians determine the best course of treatment for their patients. With 64Cu-SARTATE we are getting closer to achieving this goal, and we look forward to commencing recruitment into this pivotal trial next year."

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), such as NETs. Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu-SARTATE) or copper-67 (67Cu) for therapy (67Cu-SARTATE).

Disclaimer
64Cu-SARTATE is an unregistered product. The safety and efficacy of 64Cu-SARTATE have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration. There is no guarantee that this product will become commercially available.

About NETs
NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system6. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin7. NETs can either be benign or malignant, as well as non-functional and functional8. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon9.

Overall, it is estimated that approximately 200,000 people are living with NETs in the US10-11. Patients with NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of more than 4 years12. As such, about 30-75% of NETs patients have distant metastases at the time of diagnosis13. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%.

(Press release, Clarity Pharmaceuticals, DEC 22, 2025, View Source [SID1234661567])

On December 22, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conference:

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J.P. Morgan Healthcare Conference on Monday, January 12, 2026 beginning at 11:15 a.m. Pacific Time
The live webcast can be accessed at investors.gilead.com and the replay will be available for at least 30 days following the presentation.

(Press release, Gilead Sciences, DEC 22, 2025, View Source [SID1234661589])