A once-daily pill, daraxonrasib, nearly doubled survival in patients with advanced pancreatic cancer in a large international trial unveiled at ASCO 2026. Targeting the KRAS gene — mutated in ~90% of pancreatic cancers — it is the first pan-RAS inhibitor, opening a precision-oncology era for the deadliest of common cancers. The breakthrough also re-opens India’s familiar patents-versus-affordability debate.
Constitutional & Legal Framework
- Drugs & Cosmetics Act, 1940 (with 1945 Rules) + DCGI approval — required for marketing in India.
- Patents Act 1970, Section 84 — compulsory licence three years after grant; invoked in the Bayer Nexavar case (Natco, 2012).
- Section 3(d), Patents Act — bars “evergreening”; upheld in Novartis AG v UoI (2013) Glivec case.
- TRIPS Article 31 — international-law basis for compulsory licensing, reinforced by the Doha Declaration 2001.
- Right to Health under Article 21 — Vincent Panikurlangara v UoI (1987) and Paschim Banga Khet Mazdoor Samity v WB (1996).
- PM-JAY (Ayushman Bharat) — Rs 5 lakh annual cover including cancer care.
Why This Matters For CLAT 2027
- Section 84 compulsory licensing and the Novartis Section 3(d) ruling are perennial CLAT Legal Reasoning passages.
- The TRIPS-vs-public-health tension fits the right-to-health Article-21 thread directly.
- The numerical detail (~90% KRAS, ~20% all cancers carry RAS) makes for clean GK comprehension.
- Bayer v Natco compulsory-licence principles can be applied to a hypothetical daraxonrasib licence — classic Legal Aptitude application question.
Key Facts At A Glance
| Trial unveiling | ASCO 2026 Annual Meeting |
| Target gene | KRAS (~90% of pancreatic cancers) |
| Drug class | First pan-RAS inhibitor |
| Survival shift | 6 mo (1990s) → 9-12 mo → near-doubled |
| Indian incidence | ~23,000 new cases/yr (Tata data) |
| 5-yr survival | ~13% |
| Domestic statute | Drugs & Cosmetics Act 1940 + DCGI |
| Compulsory licence | Section 84, Patents Act 1970 |
| Evergreening bar | Section 3(d) — Novartis (2013) |
| TRIPS hook | Article 31 + Doha Declaration 2001 |
| Public-health scheme | PM-JAY — Rs 5 lakh cover |
Memory Trick / Mnemonic
KRAS → KRAS gene driver (90%) · RAS inhibitor (pan-) · ASCO 2026 unveiling · Survival doubled (6 → 12+ months).
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