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The EC has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy
Approval was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where Icotyde met all 1EP across all 4 trials (n=2,500). In the head-to-head studies, ~70% pts achieved IGA 0/1 & 55%…
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The CHMP has recommended Lifyorli (relacorilant) + nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer; EC decision is expected in Q4’26
Approval was backed by the P-II trial and P-III (ROSELLA) study assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) across the US, EU, South Korea, Brazil, Argentina, Canada…
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The CHMP has recommended Klygefa(gefurulimab; SC, QW) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are AChR antibody-positive; filings are under review in the US, China & other countries
Opinion was supported by the P-III (PREVAIL) trial assessing Klygefavs PBO in 260 gMG adults for…
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FDA has granted full approval to Inluriyo (imlunestrant; PO) + Verzenio (abemaciclib) for treating adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy (ET)
Approval was based on the P-III (EMBER-3) trial assessing Inluriyo ± Verzenio in ESR1-mutated MBC pts (n=159); Inluriyo + Verzenio (n=67) doubled the…
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The US FDA has approved Aqneursa (levacetylleucine) for the treatment of ataxia in adult & pediatric pts (≥15kg) with ataxia-telangiectasia (A-T)
Approval was backed by the P-III (IB1001-303) trial assessing Aqneursa vs PBO in 73 pts (4-50yrs.) with genetically confirmed A-T, which met its 1 & key 2EPs & showed that Aqneursa has a…
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The CHMP has recommended Zeydovio (glepaglutide) for the treatment of adults with SBS. Zealand is pursuing partnerships for the future global commercialization of Zeydovio for SBS
Opinion was based on the P-III (EASE-1) trial of Zeydovio (10mg, QW or Q2W) vs PBO in 106 SBS pts with intestinal failure (IF), dependent on parenteral support…
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The CHMP has recommended Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for pts with resectable muscle-invasive bladder cancer (MIBC); if approved, authorization would be valid in all 30 EEA states
Opinion was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj.…
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The US FDA has approved Kerendia (finerenone, 10 & 20mg) for the treatment of adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D)
Approval was supported by the global P-III (FINE-ONE) trial assessing Kerendia (10 or 20mg, QD) + SoC vs PBO in 242 pts with CKD associated with T1D
Kerendia +…
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Roche has reported the P-III (CELESTIMO) trial assessing Lunsumio (mosunetuzumab) + lenalidomide vs MabThera + lenalidomide in pts with r/r follicular lymphoma who have received ≥1L of prior systemic therapy
Trial met its 1EP, showing a statistically significant & clinically meaningful improvement in PFS, while OS data remained immature at the interim analysis; the…
Sling Therapeutics Doses First Patients in P-III (ORBIT) Trial of Linsitinib for Thyroid Eye Disease
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Sling Therapeutics has dosed the first patients in the global P-III (ORBIT) trial assessing linsitinib (150mg, PO, BID) vs PBO in ~130 adults with mod. to sev. active thyroid eye disease (TED) for 24wks.
The trial will assess the proportion of proptosis responders at Wk. 24, defined as a ≥2 mm reduction in the…

