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

13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC (Ref) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. The

09/10/2025 Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS (Ref) The US FDA granted the fast track designation to Adcendo's ADCE-D01 (uPARAP-targeting ADC) for the treatment of soft tissue sarcoma (STS). Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including STS and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific t

08/10/2025 Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC (Ref) The US FDA approved Regeneron Pharmaceuticals' Libtayo® (cemiplimab; PD-1 inhibitor) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The approval is based on results from the pivotal Phase 3 C-POST trial of adjuvant Libtayo vs placebo in patients with CSCC at high risk of recurrenc

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

30/09/2025 Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies (Ref) The US FDA granted the fast track designation to Umoja Biopharma's UB-VV111 (off-the-shelf drug product that generates CD19-directed CAR T cells in vivo) for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of

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

23/09/2025 Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA (Ref) China's NMPA has accepted Sichuan Kelun-Biotech's NDA for A400/EP0031 (RET kinase inhibitor) for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic NSCLC The acceptance for review was based on the positive results from the two pivotal Ph2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC To note, in Ma

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous administration (Ref) The EMA's CHMP adopted a positive opinion recommending the approval of Merck & Co./MSD's pembro (anti-PD-1) mono as a neoadjuvant Tx followed by adjuvant pembro + RT ± cisplatin after surgery, then pembro mono for resectable locally advanced SCCHN with PD-L1 CPS ≥1. The recommendation is based on results from the Ph3 KEYNOTE

17/09/2025 Rgenta Therapeutics' RGT-61159 received the FDA Orphan Drug Designation for ACC (Ref) The US FDA granted the Orphan Drug Designation to Rgenta Therapeutics' RGT-61159 (small molecule inhibitor of MYB) for the treatment of adenoid cystic carcinoma (ACC). The asset is currently being evaluated in a Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or colorectal cancer Travis Wager, Co-founder and CSO, Rgenta: “Granting of ODD by the FDA h

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

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC (Ref) The US FDA approved Johnson & Johnson's INLEXZO™ (TAR-200; gemcitabine intravesical system) for the treatment of adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The approval is based on results from the Phase 2b SunRISe-1/NCT04640623 trial Jennifer Taubert, Executive Vice President, Worldwide Chairman,

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

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

04/09/2025 Eli Lilly and Company's olomorasib in combination with Keytruda received the FDA Breakthrough Therapy designation for metastatic KRAS G12C-mutant NSCLC (Ref) The US FDA granted the Breakthrough Therapy designation to Eli Lilly and Company's olomorasib (KRAS G12C inhibitor) + Merck & Co/MSD's pembrolizumab (anti-PD-1), for the first-line treatment of unresectable advanced or metastatic NSCLC with a KRAS G12C mutation and PD-L1 expression ≥ 50%. The designation was b

03/09/2025 Boehringer Ingelheim's zongertinib received the FDA Breakthrough Therapy Designation for first-line HER2-mutant advanced NSCLC (Ref) The US FDA granted the Breakthrough Therapy Designation to Boehringer Ingelheim's zongertinib (HERNEXEOS; HER2-selective tyrosine kinase inhibitor) for the first-line treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain activating mutations. Vicky Brown, Senior Vi

29/08/2025 BeOne reported positive topline results for sonrotoclax in R/R MCL (Ref) BeOne Medicines' Phase 1/2 BGB-11417-201 trial of sonrotoclax (BCL2 inhibitor) met its primary endpoint of ORR in adult patients with relapsed/refractory mantle cell lymphoma following treatment with a BTK inhibitor and anti-CD20 therapy. Promising results were also observed across several secondary efficacy endpoints, including CR, DOR and PFS The safety profile was generally well-tolerated,

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer (Ref) The US FDA granted the Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. Dan Edelstein, Vice President and General Mana

20/08/2025 Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer (Ref) The US FDA granted the Orphan Drug Designation to Invion's INV043 (photodynamic therapy) for the treatment of anal cancer. Invion is working with Peter Mac to conduct an trial of INV043 in combination with ICIs in anogenital cancer including anal, vulvar and penile cancers Prof Thian Chew, Executive Chairman and CEO, Invion: “This regulatory milestone enhances our ability to bring INV0