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

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies (Ref) The US FDA accepted Orca Bio's BLA seeking approval for Orca-T (allogeneic T-cell immunotherapy) as a treatment for hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes. Priority Review status has been granted with a PDUFA target action date of April 6, 2026 The BLA submission was based on positive resul

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

01/10/2025 The US FDA accepted the sBLA for Enhertu® followed by THP for HER2+ve early-stage Breast Cancer (Ref) Daiichi Sankyo and AstraZeneca’s sBLA for famtrastuzumab deruxtecan-nxki (ENHERTU; HER2 ADC) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been accepted for review by the US FDA for the neoadjuvant treatment of adult patients with HER2 +ve stage 2/3 breast cancer. The acceptance is based on results from the Phase 3 DESTINY-Breast11 trial The PDUFA da

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction (Ref) Genmab and Merus announced a transaction agreement pursuant to which Genmab will acquire all the shares of Merus for $97.00 per share in an all-cash transaction representing a transaction value of ~$8.0 billion. The transaction has been unanimously approved by the Boards of Directors of both companies A wholly owned subsidiary of Genmab will commence a tender offer for 100% of Merus’ common

25/09/2025 Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer (Ref) The US FDA approved Eli Lilly and Company's Inluriyo (imlunestrant, oral estrogen receptor antagonist) for the treatment of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The FDA approval is based on the results of the Phase 3 EMBER-3 trial Inluriyo reduced the

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

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC (Ref) Nuvalent, Inc has completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine kinase inhibitor) in TKI pre-treated patients with advanced ROS1-positive NSCLC. SOPHiA GENETICS expanded its collaboration with AstraZeneca for an optimized NGS solution (Ref) SOPHiA GENETICS and AstraZeneca announced an expansion of their collaboration from the W

September 1st Week, 2025 Regulatory Events 🎯 China’s NMPA approved Boehringer Ingelheim’s zongertinib (HER2-selective tyrosine kinase inhibitor) monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have activating HER2 mutations and who have received at least one line of prior systemic therapy. (Ref 1) ❓ What is the development status of the regimen in other key geographies? Clinical Events 🔬 The pivotal Phase

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer (Ref) The US FDA granted the Fast Track Designation to Greenwich LifeSciences' GLSI-100 (GP2 + GM-CSF) for the treatment of patients with HLA-A*02 genotype and HER2+ve breast cancer who have completed treatment with standard of care HER2/neu targeted therapy. Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, Greenwich: "Greenwich is pleased that the FDA sees the

05/09/2025 CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML (Ref) The US FDA granted the Fast Track Designation to CERo Therapeutics' CER-1236 (TIM-4 ligand targeting CER-T therapy) for the treatment of Acute Myeloid Leukemia (AML). Chris Ehrlich, CEO, CERo Therapeutics: “These FDA designations are important additional validation with regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitt

August 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for previously treated, unresectable/metastatic non-sqNSCLC with HER2 TKD activating mutations. (Ref 1) ❓ What proportion of NSCLC patients have HER2 TKD activating mutations? 🎯 The US FDA granted accelerated approval to Jazz Pharmaceuticals' dordaviprone (DRD2 antagonist and ClpP agonist) for previously treated, H3 K27M-mutant, diff

July 4th Week, 2025 Regulatory Events 🎯 The EC approved Bayer and Orion Pharma’s darolutamide (androgen receptor inhibitor) + androgen deprivation therapy for the Tx of metastatic hormone-sensitive prostate cancer. (Ref 1) ❓ How is this approval going to impact the Tx paradigm of mHSPC? 🎯 The EC approved Roche's inavolisib (PIK3CA inhibitor) + palbociclib + fulvestrant for the Tx of PIK3CA-mutated, ER+ve, HER2-ve, LA/M breast cancer, following recurrence on or within 12

23/07/2025 Roche's Itovebi regimen received approval in the EU for ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation (Ref) The European Commission approved Roche's inavolisib (Itovebi; PIK3CA inhibitor) + palbociclib + fulvestrant for the treatment of adult patients with PIK3CA-mutated, ER+ve, HER2-ve, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment The approval is bas

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-

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer (Ref) The US FDA granted Priority Review to Johnson & Johnson's NDA filed for TAR-200 (intravesical gemcitabine releasing system) for the treatment of BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The filing was based on results from the Phase 2b SunRISe-1 trial which demonstrated a CR of 82.4% wi