On May 18, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of its anti-cancer agent/ALK inhibitor Alecensa (generic name: alectinib) for advanced or recurrent ALK fusion gene-positive solid tumors, including pediatric patients. This is the world’s first tumor-agnostic approval for an ALK inhibitor.

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"We are delighted that Alecensa, discovered by Chugai, has been approved as the world’s first tumor-agnostic therapy for patients with ALK fusion-positive solid tumors.
This approval expands access to Alecensa beyond its established use in non-small cell lung cancer and anaplastic large cell lymphoma, bringing a new treatment option to patients across a wide range of cancer types. We will continue striving to further contribute to personalized healthcare, delivering the most appropriate treatment to each patient, regardless of cancer type or age," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results of the TACKLE study, an investigator initiated Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations, and gene copy number amplification) in advanced or recurrent settings. In this study, the response rate as assessed by the central review committee, which was the primary endpoint, was 43.8% (7/16 patients, 95% CI: 19.8%-70.1%) in the full analysis set (FAS) of the main cohort. In the ALK fusion gene-positive subpopulation within this cohort, the response rate was 70.0% (7/10 patients, 95% CI: 34.8%–93.3%). In addition, in the ALK fusion gene-positive subpopulation of the overall FAS pooled across all cohorts, the response rate was 76.5% (13/17 patients, 95% CI: 50.1%-93.2%), and the efficacy data in patients with ALK fusion gene-positive tumors from this study were considered the key basis for regulatory approval. The incidence of adverse events was 73.1% (19/26 patients), with the main adverse reactions being lymphocyte count decreased, and neutrophil count decreased at 23.1% each (6/26 patients), anemia at 19.2% (5/26 patients), and blood creatinine increased at 15.4% (4/26 patients). The safety profile observed in this study was similar to the previously established safety profile of Alecensa, with no new safety signals identified.

FoundationOne CDx Cancer Genomic Profile is used as a companion diagnostic to identify people that could potentially benefit from Alecensa for ALK fusion-positive solid tumors. The MHLW granted the approval for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic of Alecensa on March 9, 2026.

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

Approval Information *Relevant sections only, with modifications underlined

Indications:
◯ ALK fusion-positive advanced or recurrent solid tumors
◯ Adjuvant treatment in ALK fusion-positive non-small cell lung cancer
◯ ALK fusion-positive recurrent or refractory anaplastic large cell lymphoma

Dosage and Administration:

The usual adult dosage is 300 mg alectinib administered orally twice a day.
The usual pediatric dosage of alectinib is based on body weight as shown below and administered orally once or twice daily.

Body Weight Daily dose Dose per administration
(morning/evening)
≥6 kg and <15 kg 150mg 150mg/0mg
≥15 kg and <25 kg 300mg 150mg/150mg
≥25 kg and <35 kg 450mg 300mg/150mg
≥35 kg 600mg 300mg/300mg
[Reference Information]

Chugai Files for Additional Tumor-Agnostic Indication of Alecensa for ALK Fusion / Rearrangement Gene-Positive Solid Tumors Including Pediatric Patients (News release issued on June 26, 2025)
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Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Alecensa for ALK Fusion Gene-Positive Solid Tumors (News release issued on May 18, 2026)
View Source

About the TACKLE study

The TACKLE study (NCCH1712/MK003, jRCT2091220364) is an investigator initiated, multicenter, open-label, single-arm, Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with unresectable rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations, gene copy number amplification). In this study, safety and efficacy were evaluated in 26 patients, utilizing genomic information, including data registered with the Center for Cancer Genomics and Advanced Therapeutics (C-CAT). The primary endpoint was response rate, and secondary endpoints included progression-free survival, overall survival, and safety. The TACKLE study is being conducted as a substudy of the MASTER KEY project,1 which promotes the development of treatments for rare cancers through industry-academia collaboration led by the National Cancer Center Hospital, and is being carried out at four sites in Japan: National Cancer Center Hospital, Kyoto University Hospital, Kyushu University Hospital, and Hokkaido University Hospital.

About ALK fusion / rearrangement gene-positive solid tumors

ALK fusion / rearrangement genes are abnormal genes created when the ALK (anaplastic lymphoma kinase) gene fuses with other genes (such as EML4, NPM) as a result of chromosomal translocation.2,3 ALK fusion / rearrangement proteins produced from these fusion / rearrangement genes are thought to promote cancer cell proliferation. ALK fusion / rearrangement genes have been identified in patients with inflammatory myofibroblastic tumors, lung cancer, breast cancer, colorectal cancer, and other cancers.2,4,5

About Alecensa

Alecensa is an oral medicine discovered by Chugai, which is highly selective for ALK and active in the central nervous system. ALK fusion / rearrangement gene-positive lung cancer is found in approximately 3-5% of NSCLC cases.4 Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK fusion / rearrangement gene-positive metastatic NSCLC, including in the United States, Europe, Japan, China, and Taiwan. For adjuvant therapy of ALK fusion / rearrangement gene-positive NSCLC, Alecensa received approval in the United States in April 2024, followed by Europe in June 2024, and Japan in August 2024. In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion / rearrangement gene-positive anaplastic large cell lymphoma.

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

(Press release, Chugai, MAY 18, 2026, View Source [SID1234665820])

On May 18, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on March 9, 2026 for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic for Alecensa (generic name: alectinib), an anti-cancer agent/ALK inhibitor for ALK fusion gene-positive solid tumors.

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This approval enables the detection of ALK fusion gene using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use Alecensa for ALK fusion gene-positive solid tumors. The efficacy and safety of Alecensa for advanced or recurrent ALK fusion gene-positive solid tumors were evaluated in an investigator initiated Japanese Phase II clinical study (TACKLE study), and an approval for a partial change to the marketing authorization was obtained on May 18, 2026.

FoundationOne CDx Cancer Genomic Profile has continuously expanded its tumor-agnostic companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment plans for multiple medicines. With the addition of Alecensa as a companion diagnostic for ALK fusion gene-positive solid tumors, beyond its already approved use in non-small cell lung cancer, the potential treatment options for patients with solid tumors are expected to expand. As a leading company in oncology, Chugai is committed to realizing more advanced personalized healthcare in the oncology field and contributing to patients through the wider adoption of comprehensive genomic profiling.

Approval information The underlined and bolded part has been newly added.

Intended uses or indications

The product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib, erlotinib, gefitinib, osimertinib, dacomitinib
EGFR exon 20 T790M alterations osimertinib
ALK fusion genes alectinib, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab
AKT1 alterations capivasertib
PIK3CA alterations
PTEN alterations
KRAS/NRAS wild-type Colorectal cancer cetuximab, panitumumab
Microsatellite instability high nivolumab
Microsatellite instability high Solid tumors pembrolizumab
Tumor mutational burden high pembrolizumab
NTRK1/2/3 fusion genes entrectinib, larotrectinib, repotrectinib
RET fusion genes selpercatinib
ALK fusion genes alectinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib, talazoparib
FGFR2 fusion genes Biliary tract cancer pemigatinib

(Press release, Chugai, MAY 18, 2026, View Source [SID1234665819])

On May 18, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported that Company management will participate in the following investor conferences:

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RBC CM Global Healthcare Conference
Date and Time: Tuesday, May 19 at 9:30 a.m. ET

William Blair’s 46th Annual Growth Stock Conference
Date: Tuesday, June 2

Jefferies Global Healthcare Conference
Date: Wednesday, June 3 at 1:20 p.m. ET

Live webcasts for the RBC and Jefferies conferences will be available on Certara’s investor relations website at View Source and will be available for replay for at least 90 days thereafter.

(Press release, Certara, MAY 18, 2026, View Source [SID1234665818])

On May 18, 2026 Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, reported that cohort 2b in the ongoing Phase I clinical trial evaluating the drug candidate 177Lu-AKIR001 has been completed. Following the safety review, the study has advanced to cohort 3. The results continue to support a favorable safety profile, enabling further dose escalation and evaluation of higher activity levels according to the study protocol.

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The trial is conducted at Karolinska University Hospital, which also serves as the study sponsor, and is designed to evaluate the safety, tolerability, and pharmacokinetic profile of the drug candidate.

In cohort 2b, the protein dose was evaluated while maintaining the same activity level as in the previous cohort. Following review of the cohort 2b data, the Safety Review Committee approved continued dose escalation, allowing the study to proceed to cohort 3.

Across the cohorts evaluated to date, no dose-limiting toxicities have been observed, and imaging data have demonstrated selective tumor uptake and accumulation in tumor tissue in treated patients. Several patients have also received repeat treatment based on medical assessment, further supporting the tolerability, manageability, and feasibility of repeated administration. Taken together, the findings support continued clinical evaluation in the ongoing trial.

Akiram’s drug candidate 177Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6 — a cancer marker associated with several aggressive tumor types — with the therapeutic radioisotope lutetium-177. Through this mechanism, radiation can be delivered selectively to tumor cells while minimizing exposure to healthy tissue.

"Advancing to cohort 3 marks an important step in our clinical development program. The results support further evaluation of dose levels, and the next stage will be central to further defining dosing parameters and treatment characteristics ahead of future stages of development," says Marika Nestor, CEO of Akiram Therapeutics.

"The decision to proceed to cohort 3 follows a thorough safety evaluation. We look forward to continuing the study and collecting additional clinical data," says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.

The trial enrolls patients with CD44v6-positive solid tumors who currently lack available treatment options.

The project is the result of a successful national collaboration between leading clinical and academic institutions in precision oncology and has been supported by the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden’s Innovation Agency.

The trial is registered at ClinicalTrials.gov: NCT06639191.

(Press release, Akiram Therapeutics, MAY 18, 2026, View Source [SID1234665817])

On May 17, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported updated results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial carcinoma (UTUC). These data will be shared during a podium presentation and in an interactive poster at the American Urological Association (AUA) Annual Meeting taking place May 15-18, 2026, in Washington, D.C.

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"These updated efficacy and durability results from the Phase 3 ENLIGHTED trial continue to reinforce Padeliporfin VTP’s potential to become an attractive alternative, minimally invasive ureteroscopic treatment option for patients with low-grade UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "The promising complete response rate and encouraging durability observed to date, alongside a well-established safety profile, further support the opportunity to provide a meaningful organ-sparing treatment for patients with limited options in UTUC and additional solid tumor indications. We look forward to sharing topline data from ENLIGHTED later this year and preparing for regulatory submission in 2027, while exploring strategic opportunities to commercialize the program and maximize Padeliporfin VTP’s impact for UTUC patients facing great unmet need."

Key updated results from the ongoing Phase 3 ENLIGHTED study of Padeliporfin VTP:

As of April 20, 2026, the data cut-off for the poster presentation at AUA 2026, 82 patients had begun treatment, of which 72 had completed PRE and were evaluable for efficacy.

Efficacy Profile:

Overall response rate: 88%
50 of the 72 (70%) response-evaluable patients achieved a CR at the end of PRE.
13 of the 72 (18%) response-evaluable patients achieved a partial response (PR) at the end of PRE.

Durability Profile:

18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, with additional patients ongoing the MTP that have yet to complete the 12-month evaluation period. Padeliporfin VTP treatment has demonstrated evidence of efficacy and durability.
The current median duration of response (DoR) in the treated area for evaluable patients is 23.9 months based on available follow-up, with ongoing responses still being observed.

Safety and Tolerability Profile:

Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results. Padeliporfin VTP treatment has demonstrated a consistent and acceptable safety profile.
Adverse events (AEs): the majority of treatment-emergent adverse events (TEAEs) were mild or moderate, primarily related to the ureteroscopic procedure, and resolved within a few days. Two patients had Grade 3 serious adverse events related to VTP treatment which resolved within two days. No TEAEs of special interest were reported and no TEAE led to discontinuation of the study treatment.

While the Company is pursuing strategic partnering opportunities to support the commercialization of its low-grade UTUC program, ImPact recently presented initial data supporting the advancement of Padeliporfin VTP in locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) at the Society of Interventional Radiology (SIR) 2026 Annual Meeting, which demonstrated a consistent tolerability profile alongside early signs of clinical efficacy, showing potential to convert patients with unresectable stage III LA tumors to surgically resectable candidates.

Additional updates from both programs will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

AUA Presentation Details:

Interactive Poster Title: The ENLIGHTED Phase 3 Trial: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: IP30-04
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma I
Session Date & Time: Saturday, May 16, 2026 at 7:00 AM ET

Podium Presentation Title: ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC)
Presenter: Jonathan Coleman, M.D., Urologic Surgeon, Memorial Sloan Kettering Cancer Center
Session Title: Clinical Trials in Progress: Bladder Cancer
Session Date & Time: Sunday, May 17, 2026 at 9:16 AM ET

About ENLIGHTED
The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of
the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an ureteroscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

(Press release, ImPact Biotech, MAY 17, 2026, View Source [SID1234665816])