February 1st Week, 2026 Regulatory Events 🎯 The US FDA approved an update to Gilead Sciences' axicabtagene ciloleucel (anti-CD19 CAR-T) prescribing information removing the previous “Limitations of Use” in patients with relapsed/refractory primary central nervous system lymphoma (Ref 1) ❓ How would this decision alter Yescarta’s positioning in the market landscape? 🎯 AstraZeneca and Daiichi Sankyo US’ sBLA for datopotamab deruxtecan (TROP2 ADC) was accepted and granted a Pr

January 2nd Week, 2026 Regulatory Events 🎯 Summit Therapeutics, Inc. has submitted a biologics license application to the US FDA seeking approval for Akeso Biopharma & Summit's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC. (Ref 1) ❓ What are the launch timeline estimates for the regimen in this indication? Special Designations ⭐ The US FDA granted the regenera

November 3rd Week, 2025 Regulatory Events 🎯 The EC granted approval to Merck & Co./MSD's subcutaneous formulation of pembrolizumab (KEYTRUDA SC, anti-PD-1) for use across all 33 KEYTRUDA indications for adult patients in Europe. (Ref 1) ❓ What are the key pros and cons of this SC formulation? 🎯 The EC granted approval to Regeneron's cemiplimab (anti-PD-1) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surg

September 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Johnson & Johnson Innovative Medicine's INLEXZO (TAR-200; gemcitabine intravesical system) for the Tx of adults with BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 The US FDA accepted Corcept Therapeutics' NDA for relacorilant (selective glucocorticoid receptor antagonist) as a Tx

12/09/2025 The NDA for Alphamab Oncology and CSPC Pharma's anbenitamab + chemo has been accepted by the NMPA for HER2 +ve GC/GEJC (Ref) China's National Medical Products Administration accepted the NDA for Alphamab Oncology and CSPC Pharma's anbenitamab injection (KN026; anti-HER2 BsAb) in combination with chemotherapy for the treatment of HER2 +ve, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior system

08/09/2025 Beyond Air's BA-101 received the Orphan Drug Designation for GBM (Ref) The US FDA granted the Orphan Drug Designation to Beyond Air's BA-101 for the treatment of Glioblastoma (GBM). Amir Avniel, CEO, NeuroNOS: “We are pleased to receive orphan drug designation from the FDA for the treatment of glioblastoma. This is our second orphan drug designation and further highlights our mission to bring targeted therapies to individuals and families affected by rare neurologi

August 4th Week, 2025 Regulatory Events 🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + platinum-containing chemo as neoadjuvant Tx followed by tislelizumab monotherapy as adjuvant Tx for resectable NSCLC at high risk of recurrence. (Ref 1) ❓ How is BeOne’s regimen positioned compared to other approved perioperative options? Clinical Events 🔬 Per final analysis of the Phase 3 HARMONi-A trial, a statistically significant and clinically meaningful OS benef

July 3rd Week, 2025 Regulatory Updates 🎯 Corcept Therapeutics submitted an NDA to the US FDA for relacorilant (selective cortisol modulator) to treat patients with platinum-resistant ovarian cancer. (Ref 1) ❓ What are the clinical outcomes that support the NDA submission? Special Designations ⭐ The US FDA granted the Priority Review to Johnson & Johnson Innovative Medicine’s TAR-200 (intravesical gemcitabine releasing system) for the Tx of BCG unresponsive high-risk non-

15/07/2025 The first patient has been enrolled in the Phase 3 HARMONi-GI6 trial of ivonescimab + chemo in CRC (Ref) The first patient has been successfully enrolled in the registration Phase 3 AK112-312/HARMONi-GI6 trial of Akeso and Summit's ivonescimab (PD-1 x VEGF BsAb) in first-line treatment for advanced metastatic colorectal cancer (mCRC) The trial is evaluating ivonescimab + FOLFOXIRI vs bevacizumab + FOLFOXIRI Primary completion date: Jan'27

30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab combinations in RAS Mutant Tumors (Ref) Revolution Medicines and Summit Therapeutics entered into a clinical collaboration to evaluate the safety and efficacy of Revolution Medicines’ daraxonrasib (multi-selective RAS(ON) inhibitor), zoldonrasib (G12D-selective inhibitor) and elironrasib (G12C-selective inhibitor), in combination with Akeso & Summit

June 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved the updated labelling of Pfizer’s talazoparib (PARP inhibitor) + enzalutamide (androgen receptor inhibitor) for mCRPC to include the final OS data for the combo’s existing indication for the Tx of HRR gene-mutated mCRPC, but did not expand the indication to include non-HRR gene mutated patients. (Ref 1) ❓ What were the key factors that influenced the FDA’s decision to not expand the indication? 🎯 The US FDA appr

May 2nd Week, 2025 Special Designations ⭐ The US FDA granted the Fast Track designation to Adcentrx Therapeutics’ ADRX-0706 (Nectin-4 ADC) for the Tx of locally advanced or metastatic squamous cell cervical cancer. (Ref 1) ❓ What are the outcomes of ADRX-0706 that supported the Fast Track designation? ⭐ The US FDA granted the Fast Track designation to Glenmark Pharmaceuticals (Ichnos Glenmark Innovation)’s ISB2001 (BCMA x CD38 x CD3 trispecific antibody) for the Tx of R/R mu

May 1st Week, 2025 Regulatory Events 🎯 Summit Therapeutics, Inc. and Akeso Biopharma’s ivonescimab (PD-1 x VEGF BsAb) mono has been approved in China for the 1L Tx of NSCLC with PD-L1 ≥1%. (Ref 1) ❓ When can we expect ivonescimab to receive the first approval in the key markets? 🎯 The UK’s MHRA approved Bristol Myers Squibb’s nivolumab (anti-PD-1) subcutaneous formulation for a broad range of cancers, including kidney, melanoma, lung, head and neck, bladder, colorectal,

April 1st Week, 2025 Regulatory Events 🎯 AstraZeneca's neoadjuvant durvalumab (anti-PD-L1) + chemo followed by adjuvant durvalumab mono has been approved for adults with resectable NSCLC at a high risk of recurrence and no EGFR mutations or ALK rearrangements in the EU. (Ref 1) ❓ What are the other approved regimens in the early-stage NSCLC, and how do the outcomes of the AEGEAN regimen compare against those regimens? 🎯 The US FDA approved AstraZeneca’s neoadjuvant durval

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) ❓ How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? 🎯 Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)

February 4th Week, 2025 📝 Merck & Co/ MSD's sBLA for neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin in resectable, LA SCCHN has been accepted by the US FDA for priority review (PDUFA date: Jun 23, 2025) (Ref 1) ❓ It is set to be the first approved Tx option for perioperative LA SCCHN. What are its challengers in the pipeline? 📝 BMS’ sBLA for nivo + ipi as a 1L Tx for adult and pediatric patients with unresectable or metastatic, MSI-H/dMMR colorectal canc

February 3rd Week, 2025 📝With the Ph3 CHECKMATE-816 trial meeting its key secondary endpoint of OS, BMS’ nivo + platinum-doublet CT became the first neoadjuvant-only Tx to significantly improve OS in resectable NSCLC patients. (Ref 1) ❓Will the positive OS data support BMS’ regimen in tackling the competitive threat from the perioperative chemo-IO regimens? 📝The US FDA will be assessing BI's NDA of zongertinib (irreversible ERBB2 TKI) for previously treated, HER2+ve, unres