June 1st Week, 2026 Regulatory Updates 🎯 Australia’s Therapeutic Goods Administration (TGA) has conditionally approved Iovance Biotherapeutics, Inc.'s lifileucel (Amtagvi®; tumor infiltrating lymphocytes), making it the first T cell therapy for a solid tumor and the first treatment option in Australia for advanced melanoma in adults, after anti‑PD‑1 and targeted therapy (Ref) ❓ Which other regimens have the potential to challenge lifileucel in this setting? 🎯 The U

Highlights from the CHMP Apr 2026 Meeting are out! New Generics 💊 Viatris' palbociclib (Palbociclib Viatris; CDK4/6 inhibitor) for the treatment of HR+ HER2- locally advanced or metastatic breast cancer either in in combination with an aromatase inhibitor, or in combination with fulvestrant in women who have received prior endocrine therapy Indication Expansions 💊 Otsuka Pharmaceutical Companies (U.S.)'s fixed‑dose oral combination of decitabine‑cedazuridine (Inaqovi; hypom

December 4th Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Roche's Lunsumio VELO (mosunetuzumab; CD20 x CD3 BsAb), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. (Ref 1) ❓ What are the key pros and cons of this subcutaneous therapy? Clinical Events 🔬 The Phase 3 LATIFY trial of AstraZeneca's ceralasertib (ATR kinase inhibitor) + durv

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

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

April 2nd Week, 2025 Regulatory Events 🎯AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (HER2 ADC) mono has been approved in the EU for the Tx of unresectable/metastatic HR+ve, HER2-low/ultralow breast cancer patients who have received at least one endocrine Tx in the metastatic setting and who are not suitable for endocrine Tx as the next line of Tx. (Ref 1) ❓What is the status of trastuzumab deruxtecan for these patients in other key markets? 🎯AstraZeneca and D

March 3rd Week, 2025 Regulatory Events 🎯 The US FDA granted traditional approval to Merck & Co./MSD’s pembrolizumab (anti-PD-1) + trastuzumab (anti-HER2) + fluoropyrimidine- and platinum-containing chemo for the first-line treatment of adults with locally advanced, unresectable/metastatic HER2+ve gastric/gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1 (Ref 1). The regimen was previously granted accelerated approval for this indication in May’21. ❓ Which other re