This week’s Oncology update highlights regulatory approvals, late-stage trial initiations, emerging clinical data, and ongoing pipeline developments across solid tumors and novel therapeutic modalities.
In Today’s Newsletter
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🧠 Ojemda wins EU approval in pediatric low-grade glioma [1] [EU • 22 Apr 2026]
https://www.ipsen.com/press-release/ojemda-approved-in-the-european-union-as-the-first-targeted-therapy-in-relapsed-or-refractory-pediatric-low-grade-glioma-regardless-of-braf-alteration-3278647/
Context: Ojemda (Ipsen; tovorafenib) is a once-weekly oral Type II RAF inhibitor evaluated in FIREFLY-1 in relapsed or refractory BRAF-altered pLGG.
Key point: European Commission granted conditional marketing authorization for patients 6 months and older with pLGG harboring BRAF fusion, rearrangement, or V600 mutation after prior systemic therapy.
Implication: May influence prescriber choice and payer reviews pending full data.
🎯 Mabwell starts Phase III TNBC study for 9MW2821 [2] [China • 23 Apr 2026]
https://mabwell.com/en/news_info/id-217.html
Context: 9MW2821 (Mabwell; Nectin-4 ADC) is being compared with investigator’s choice chemotherapy in locally advanced or metastatic TNBC after prior taxane-based chemotherapy and TOPi-ADC therapy.
Key point: Mabwell initiated a randomized, open-label, controlled, multicenter Phase III study, described as the fourth pivotal trial for 9MW2821.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Opamtistomig enters Phase II gastric cancer trial [3] [China • 21 Apr 2026]
https://en.leadsbiolabs.com/pressCenter/detail/dynamicDetail?id=200
Context: Opamtistomig (Leads Biolabs; LBL-024) is a PD-L1/4-1BB bispecific antibody being studied in first-line locally advanced or metastatic gastric or GEJ adenocarcinoma.
Key point: Leads Biolabs dosed the first patient in an open-label, multicenter Phase II study evaluating efficacy and safety.
Implication: Signals pipeline investment and modality expansion.
🧪 Annamycin shows preclinical PDAC activity at AACR [4] [US • 23 Apr 2026]
https://moleculin.com/moleculins-annamycin-extends-survival-by-more-than-60-in-metastatic-pancreatic-cancer-preclinical-models-data-presented-at-aacr-2026/
Context: Annamycin (Moleculin; liposomal non-cardiotoxic anthracycline) was tested across pancreatic ductal adenocarcinoma preclinical models.
Key point: Moleculin reported tumor growth inhibition and median survival of 29 days versus 18 days in a metastatic model, with immune-cell infiltration findings.
Implication: Signals pipeline investment and modality expansion.
🧫 Ozekibart shows interim activity in late-line CRC [5] [US • 21 Apr 2026]
https://inhibrxbiosciences.investorroom.com/2026-04-21-Inhibrx-Provides-Clinical-Update-on-Ozekibart-INBRX-109-in-Late-Line-Colorectal-Cancer
Context: Ozekibart (Inhibrx; INBRX-109) plus FOLFIRI is being evaluated in locally advanced or metastatic unresectable colorectal cancer.
Key point: Inhibrx reported interim activity in a heavily pretreated CRC cohort, with responses, disease control, and manageable safety.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Allarity highlights stenoparib and DRP data at AACR [6] [US • 21 Apr 2026]
https://allarity.com/press-release/allarity-therapeutics-presents-two-aacr-2026-posters-highlighting-stenoparibs-potential-in-colorectal-cancer-as-well-as-new-predictive-data-linking-drp-and-overall-survival-in-ovarian-c/
Context: Stenoparib (Allarity; 2X-121) is an oral dual PARP/tankyrase inhibitor paired with Allarity’s DRP companion diagnostic approach.
Key point: Allarity presented AACR posters linking higher DRP scores with enhanced OS in ovarian cancer and showing WNT-pathway modulation in CRC cell lines.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
💉 Epitopea gets UK CTA approval for OVACT [7] [UK • 23 Apr 2026]
https://www.epitopea.com/epitopea-announces-approval-of-ovact-clinical-trial-application-for-cryptivax-1001-in-advanced-high-grade-serous-ovarian-cancer/
Context: CryptiVax-1001 (Epitopea; off-the-shelf mRNA therapeutic vaccine) targets advanced HRP+/BRCA-wildtype high-grade serous ovarian cancer.
Key point: Epitopea received MHRA and ethics approval for OVACT, a Phase 1/1b dose-escalation and expansion trial.
Implication: Signals pipeline investment and modality expansion.
🚻 PADCEV plus Keytruda gets FDA Priority Review in MIBC [8] [US • 20 Apr 2026]
https://www.pfizer.com/news/press-release/press-release-detail/us-fda-grants-priority-review-sbla-padcevtm-keytrudar
Context: PADCEV (Astellas, Pfizer; enfortumab vedotin) plus Keytruda (Merck; pembrolizumab) was evaluated in EV-304/KEYNOTE-B15 in perioperative MIBC.
Key point: FDA accepted the sBLA for Priority Review to expand use regardless of cisplatin eligibility, with a PDUFA target date of 17 Aug 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Orion’s ODM-212 receives FDA orphan status [9] [US • 20 Apr 2026]
https://www.orionpharma.com/newsroom/all-news/releases/press-releases/2026/orion-pharmas-odm-212-granted-orphan-drug-designation-in-mesothelioma-by-the-us-fda/
Context: ODM-212 (Orion Pharma) is an oncology program in mesothelioma.
Key point: FDA granted orphan drug designation to ODM-212 in mesothelioma.
Implication: Introduces competition that may affect pricing and formulary access.
📉 Novartis withdraws EMA Pluvicto application [10] [EU • 24 Apr 2026]
https://www.novartis.com/news/novartis-withdraws-ema-application-adding-new-indication-pluvicto
Context: Pluvicto (Novartis) was the subject of an EMA application for an added indication.
Key point: Novartis withdrew its EMA application to add a new indication for Pluvicto.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Regulatory activity shaped the week, with EU authorization for Ojemda, FDA Priority Review for PADCEV plus Keytruda, FDA orphan status for ODM-212, UK CTA approval for CryptiVax-1001, and an EMA withdrawal for Pluvicto [1][7][8][9][10].
- Nectin-4 remained active, with Mabwell moving 9MW2821 into Phase III TNBC and Astellas, Pfizer, and Merck seeking broader perioperative MIBC use for PADCEV plus Keytruda [2][8].
- Gastrointestinal oncology updates spanned a PD-L1/4-1BB bispecific in gastric or GEJ cancer, a DR5 agonist in CRC, and preclinical pancreatic cancer data for Annamycin [3][4][5].
- Ovarian cancer development advanced through two different approaches, Allarity’s biomarker-linked stenoparib work and Epitopea’s off-the-shelf mRNA vaccine CTA [6][7].
- The Pluvicto withdrawal is a reminder that oncology label expansions can change course during regulatory review [10].
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FAQ
What changed for Ojemda in Europe?
The European Commission granted conditional marketing authorization for Ojemda in relapsed or refractory BRAF-altered pediatric low-grade glioma after prior systemic therapy. Ipsen said the decision applies across EU Member States plus Iceland, Liechtenstein, and Norway [1].
Why is Mabwell’s 9MW2821 update notable?
Mabwell started a Phase III trial of 9MW2821 in locally advanced or metastatic TNBC after prior taxane-based chemotherapy and TOPi-ADC therapy. The company described this as the fourth pivotal trial for the Nectin-4 ADC [2].
What did Inhibrx report for ozekibart in colorectal cancer?
Inhibrx reported interim activity for ozekibart plus FOLFIRI in heavily pretreated locally advanced or metastatic unresectable CRC. The dataset remains interim [5].
What is the FDA reviewing for PADCEV plus Keytruda?
FDA granted Priority Review to an sBLA for perioperative PADCEV plus Keytruda in MIBC regardless of cisplatin eligibility. The PDUFA target date is 17 Aug 2026 [8].
What does Orion’s ODM-212 orphan designation mean?
FDA granted orphan drug designation to ODM-212 in mesothelioma. Orphan designation is a regulatory development incentive and does not equal approval [9].
What happened with Novartis and Pluvicto at EMA?
Novartis withdrew its EMA application to add a new indication for Pluvicto. The supplied source title does not provide enough detail here to characterize the reason for withdrawal [10].
Entities / Keywords
Ojemda, tovorafenib, Ipsen, Day One Biopharmaceuticals, pediatric low-grade glioma, pLGG, BRAF fusion, BRAF rearrangement, BRAF V600 mutation, FIREFLY-1, European Commission, conditional marketing authorization, 9MW2821, Mabwell, Nectin-4 ADC, triple-negative breast cancer, TNBC, topoisomerase inhibitor ADC, TOPi-ADC, Opamtistomig, LBL-024, Leads Biolabs, PD-L1/4-1BB bispecific antibody, gastric cancer, gastroesophageal junction adenocarcinoma, GEJ adenocarcinoma, Annamycin, Moleculin Biotech, liposomal anthracycline, pancreatic ductal adenocarcinoma, PDAC, AACR 2026, ozekibart, INBRX-109, Inhibrx Biosciences, DR5 agonist, FOLFIRI, colorectal cancer, CRC, stenoparib, 2X-121, Allarity Therapeutics, PARP inhibitor, tankyrase inhibitor, WNT pathway, DRP, Drug Response Predictor, ovarian cancer, CryptiVax-1001, Epitopea, OVACT, mRNA therapeutic vaccine, high-grade serous ovarian cancer, HGSOC, HRP, BRCA-wildtype, PADCEV, enfortumab vedotin, Astellas, Pfizer, Keytruda, pembrolizumab, Merck, EV-304, KEYNOTE-B15, muscle-invasive bladder cancer, MIBC, sBLA, Priority Review, PDUFA, ODM-212, Orion Pharma, mesothelioma, Pluvicto, Novartis, EMA
References
- https://www.ipsen.com/press-release/ojemda-approved-in-the-european-union-as-the-first-targeted-therapy-in-relapsed-or-refractory-pediatric-low-grade-glioma-regardless-of-braf-alteration-3278647/
- https://mabwell.com/en/news_info/id-217.html
- https://en.leadsbiolabs.com/pressCenter/detail/dynamicDetail?id=200
- https://moleculin.com/moleculins-annamycin-extends-survival-by-more-than-60-in-metastatic-pancreatic-cancer-preclinical-models-data-presented-at-aacr-2026/
- https://inhibrxbiosciences.investorroom.com/2026-04-21-Inhibrx-Provides-Clinical-Update-on-Ozekibart-INBRX-109-in-Late-Line-Colorectal-Cancer
- https://allarity.com/press-release/allarity-therapeutics-presents-two-aacr-2026-posters-highlighting-stenoparibs-potential-in-colorectal-cancer-as-well-as-new-predictive-data-linking-drp-and-overall-survival-in-ovarian-c/
- https://www.epitopea.com/epitopea-announces-approval-of-ovact-clinical-trial-application-for-cryptivax-1001-in-advanced-high-grade-serous-ovarian-cancer/
- https://www.pfizer.com/news/press-release/press-release-detail/us-fda-grants-priority-review-sbla-padcevtm-keytrudar
- https://www.orionpharma.com/newsroom/all-news/releases/press-releases/2026/orion-pharmas-odm-212-granted-orphan-drug-designation-in-mesothelioma-by-the-us-fda/
- https://www.novartis.com/news/novartis-withdraws-ema-application-adding-new-indication-pluvicto