24/06/2026 US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (TNBC) EU approves KEYTRUDA + Padcev as first PD-1 + ADC perioperative regimen for cisplatin-ineligible MIBC IBRANCE secures US FDA approval as the first CDK4/6 inhibitor for HR+, HER2+ metastatic breast cancer maintenance US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizu

22/06/2026 Exelixis’ STELLAR-303 trial showed OS benefit in ITT, non‑significant trend in NLM in mCRC; FDA decision due Dec 2026 SystImmune secures world’s first bispecific ADC approval with iza-bren in China CARsgen secures NMPA approval for satri-cel, the world’s first CAR-T therapy in solid tumors, targeting Claudin18.2-positive advanced gastric cancer Sigvotatug vedotin in metastatic non-squamous NSCLC missed OS in the overall population but showed promising efficacy in s

12/05/2026 FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid cystic carcinoma Rigel secures global rights to VEPPANU, the first FDA‑approved oral PROTAC, with strong Phase 3 data in ER+/HER2‑, ESR1‑mutated breast cancer ZUSDURI delivers 64.5% 3‑year event‑free durability in recurrent LG‑IR‑NMIBC FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid

24/02/2026 Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC Siren Biotechnology's SRN-101 received the FDA fast track designation for HGG Aktis Oncology's AKY-1189 received the FDA fast track designation for mUC Onconic Therapeutics' nesuparib received the FDA orphan drug designation for SCLC Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC (Ref) The US FDA granted traditional approval to Pfizer's encorafenib

01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia (Ref) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for th

14/10/2025 Pfizer's tucatinib combination regimen significantly improved PFS as a 1L maintenance therapy in HER2+ve metastatic Breast Cancer (Ref) Per topline results from the Phase 3 HER2CLIMB-05 trial, Pfizer's tucatinib (tyrosine kinase inhibitor) in combination with first-line standard-of-care maintenance therapy (trastuzumab plus pertuzumab) following chemotherapy-based induction met its primary endpoint of PFS in HER2+ metastatic breast cancer. A statistically significa

08/08/2025 Boehringer Ingelheim's Hernexeos received accelerated approval from the US FDA for HER2-mutant advanced NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (Hernexeos; kinase inhibitor) for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. The approval is based on data from the Phase 1b Bea

Highlights from the CHMP Apr 2025 Meeting are out! ⭐ New Medicines 💊 Jazz Pharmaceuticals and BeiGene's zanidatamab (Ziihera; dual HER2-targeted BsAb) monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2+ve biliary tract cancer previously treated with at least one prior line of systemic therapy ⭐ New Biosimilars 💊 CuraTeQ Biologics' trastuzumab (Dazublys; HER2 inhibitor) is indicated for the treatment of HER2+ve metastat

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive recommendations in the Oncology space (Ref 1): ⭐ New Therapies: 👉 AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (TROP2-directed ADC) for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer (post-endocrine therapy + chemo) 👉 Pfizer, Zai Lab, and Genmab's tisotumab vedotin (tissue factor-di

Bladder cancer is the most common malignancy of the urinary tract. As of 2022, Bladder Cancer had an incidence of 614,298 patients worldwide, and 220,596 patients succumbed to the disease. While the therapeutic approach to it remained largely unchanged for many years, recent clinical progress has paved the way towards a novel era of diagnosis and management of the disease, with several special designations and two very recent approvals by the US FDA. In December 2023, the FD

Esophageal cancer is the fourteenth most commonly diagnosed cancer and the eighth leading cause of cancer-related death worldwide. The burden of esophageal cancer incidence and mortality is steadily increasing worldwide due to increased prevalence of associated risk factors such as tobacco and alcohol consumption, poor diet, sedentary lifestyle and obesity. Despite advancements in targeted therapies and immunotherapies, the prognosis of Esophageal cancer remains dismal, with

Renal cell carcinoma (RCC) stands as the predominant form of kidney cancer, comprising about 90% of kidney cancer cases. It accounts for roughly 3% of all cancer diagnoses, with a notably higher occurrence in Western countries, likely linked to the increased detection of small renal masses. Despite advancements in targeted therapies and immunotherapies, the prognosis for stage IV RCC remains challenging, with a 5-year survival rate of only 17%. Furthermore, non-clear cell RCC

Acute myeloid leukemia (AML) is the most common type of leukemia among the adult population and accounts for about 80% of all cases. Despite development of novel treatment options and targeted therapeutics, the 5-year survival rate in adult population is quite low, indicating towards a huge unmet need in AML treatment space. The current infographic concisely highlights the key treatment options for AML and some of the emerging therapeutic stratagems.

Breast cancer is the most commonly diagnosed cancer worldwide with a steady increase in incidence rate over the past decades. It is estimated that, if the current trends remain unchanged, the burden of breast cancer is set to grow to over 3 million new cases and 1 million deaths per year by 2040 as a result of population growth and ageing alone. The infographic highlights the current key options in Breast cancer's evolving treatment paradigm with a glimpse of the emerging the