17/08/2026 Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC AstraZeneca halts Phase 3 eVOLVE-Lung02 trial of volrustomig in mNSCLC ORPATHYS + TAGRISSO deliver survival benefit in MET-driven EGFRm NSCLC US FDA fast track designation granted for PIKTOR + paclitaxel in biomarker-selected advanced Endometrial Cancer UroGen submits NDA for UGN-103 in recurrent LG-IR-NMIBC Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC (Ref) AstraZeneca and Daiichi S

19/02/2026 Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC Genentech's NDA for giredestrant + everolimus has been accepted by the US FDA for certain patients with breast cancer Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer (Ref) The EMA has validated the type II variation marketing authoriz

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

22/12/2025 Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan received the FDA breakthrough therapy designation for early breast cancer AstraZeneca's ceralasertib + durvalumab failed to meet the OS endpoint in PD(L)-1 failed NSCLC Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma (Ref) The US FDA granted accelerated approval to Roche's Lunsumio VELO

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Jazz Pharmaceuticals' lurbinectedin (DNA alkylating agent) + Roche's atezolizumab (anti-PD-L1) as a maintenance Tx for adults with ES-SCLC whose disease has not progressed after first-line induction Tx with atezolizumab, carboplatin and etoposide. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (HER2 ADC) followed by paclitaxel

September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved Eli Lilly and Company's imlunestrant (oral estrogen receptor antagonist) for the Tx of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 Nuvalent, Inc., completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine

24/09/2025 AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast cancer (Ref) The US FDA accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (Enhertu; HER2 ADC) + pertuzumab for the first-line Tx of adult patients with unresectable or metastatic HER2-positive breast cancer. The PDUFA date is anticipated during Q1'26 The sBLA was based on results from th

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-

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 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)

Highlights from the CHMP Feb 2025 Meeting are out! Here are the positive recommendations in the Oncology space: ⭐ New Therapies: 👉 Regeneron's linvoseltamab (BCMA x CD3 BsAb) mono for the treatment of adult patients with R/R multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38, and have demonstrated disease progression on the last therapy ⭐ Indication expansions: 👉 AstraZeneca's acalabru

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Gastric cancer has remained one of the leading causes of cancer-related deaths globally. It was reported as the 5th most common cancer and the 4th leading cause of cancer death worldwide in 2020, with an observed trend of increasing incidence rates in younger adults (<50 years). Despite therapeutic progress, the survival rate for gastric cancer patients remains low, highlighting the unmet need for treatments of further potential. In this concise infographic, we highlight the

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