Onco-Summaries: Daily Oncology Updates at a Glance

14/05/2026

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• Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg

  
  

• In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC

  
  

• Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients

  
  

• Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit

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Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg (Ref)

Alembic received USFDA tentative approval for its Abbreviated New Drug Application (ANDA) for Darolutamide Tablets, 300 mg

• The product is therapeutically equivalent to Bayer’s Nubeqa Tablets, 300 mg

Darolutamide is an androgen receptor inhibitor indicated for:

• Non‑metastatic castration‑resistant prostate cancer (nmCRPC)

• Metastatic castration‑sensitive prostate cancer (mCSPC)

• mCSPC in combination with docetaxel

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In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC (Ref)

Perioperative Imfinzi (durvalumab) + neoadjuvant enfortumab vedotin (EV) significantly improved event-free survival (EFS) and showed a clinically meaningful benefit in overall survival (OS) compared to surgery alone in patients with muscle-invasive bladder cancer (MIBC) who were ineligible for or declined cisplatin chemotherapy

The addition of Imjudo (tremelimumab) to Imfinzi + EV also improved EFS and showed a favorable OS trend, though OS was not statistically significant at this interim analysis

The regimen’s safety profile was consistent with known data; no new safety signals were observed

Detailed results will be presented at a forthcoming medical meeting and shared with global regulatory authorities

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Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients (Ref)

VIKTORIA-2 now includes endocrine-sensitive HR+/HER2- advanced breast cancer patients, in addition to endocrine-resistant patients

• Patients are manually assigned to Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive), then randomized to treatment arms

• Each study has independent statistical plans and primary endpoints, with progression-free survival (PFS) as the main endpoint assessed by blinded review

Phase 1b results in endocrine-sensitive patients showed median PFS of 48.6 months, OS of 77.3 months, and 79% response rate with gedatolisib + palbociclib + letrozole

Celcuity submitted its first patent application for a subcutaneous gedatolisib formulation, aiming to provide an injection alternative to IV infusion

FDA has accepted Celcuity’s NDA for gedatolisib in HR+/HER2-/PIK3CA WT advanced breast cancer, with a Priority Review and PDUFA date of July 17, 2026

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Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit (Ref)

Astellas filed a supplemental new drug application (sNDA) in Japan for PADCEV™ (enfortumab vedotin) + Keytruda® (pembrolizumab) as neoadjuvant and adjuvant therapy in cisplatin-eligible muscle-invasive bladder cancer (MIBC) patients

The application is supported by results from the Phase 3 EV-304 (KEYNOTE-B15) trial, comparing PADCEV + Keytruda with standard gemcitabine + cisplatin chemotherapy

• 47% reduction in risk of recurrence, progression, or death (Event-Free Survival)

• 35% reduction in risk of death (Overall Survival)

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