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

Highlights from the CHMP Mar 2026 Meeting are out! New Medicines 💊 Ferring Pharmaceuticals ’ nadofaragene firadenovec gene therapy for the Tx of adults with BCG-unresponsive NMIBC with CIS with/without papillary tumours 💊 Amgen 's tarlatamab (DLL3 x CD3 BsAb) for the Tx of adults with ES-SCLC, who require systemic therapy following disease progression on or after 1L Tx with platinum-based chemo 💊 PharmaMar & Jazz Pharmaceuticals ' lurbinectedin (alkylating agent) + at

March 3rd Week, 2026 Regulatory Events 🎯 The US FDA approved Bristol Myers Squibb 's nivolumab (anti-PD-1) + doxorubicin + vinblastine + dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III/IV cHL. Additionally, the EC approved nivolumab + brentuximab vedotin for the treatment of children 5 years of age and older, adolescents, and adults up to 30 years of age with R/R cHL after one prior line of therapy. (Ref

March 2nd Week, 2026 Regulatory Events 🎯 The EC has approved an indication extension for Johnson & Johnson Innovative Medicine 's AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone in combination with androgen deprivation therapy, for the treatment of patients with metastatic hormone-sensitive prostate cancer and BRCA1/2 mutations (germline and/or somatic). (Ref 1) ❓ How do the outcomes of this regimen compare against the other ap

March 1st Week, 2026 Regulatory Events 🎯 The European Commission approved Incyte ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal. (Ref 1) ❓ How do the outcomes of this regimen compare against the current SOC? 🎯 The US FDA approved Johnson & Johnson Innovative Medicine ’s teclistamab (BCMA-directed CD3 T-cell engager) + daratu

Highlights from the CHMP Feb 2026 Meeting are out! New Medicines 💊 Ipsen 's tovorafenib (Ojemda; Type II RAF kinase inhibitor) is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low‑grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies New Biosimilars 💊 Henlius and Organon 's pertuzumab (Poherdy; HER2/neu receptor antagonist), an

Bristol Myers Squibb 's Q4 2025 earnings call spotlighted key milestones for the Opdualag franchise in melanoma 📊 Blockbuster Status and US Dominance Four years post-launch, Opdualag reached blockbuster status with 2025 global revenues of $1,185M, driven by $1,045M in the US. It has captured over 30% US market share, cementing its role as a standard-of-care option for metastatic melanoma. The ex-US market remains largely untapped with sales generating only $140M, constrained

February 2nd Week, 2026 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD 's Keytruda (pembrolizumab; anti-PD-1) as well as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph subcutaneous product) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1), and who have received one or two prior systemic treatment

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 rege

January 1st Week, 2026 Clinical Events 🔬 Per primary analysis from the Phase 3 HERIZON-GEA-01 trial, Jazz Pharmaceuticals , BeOne Medicines and Zymeworks Inc. 's zanidatamab (bispecific HER2-directed antibody) + chemo ± BeOne Medicines ' tislelizumab (anti-PD-1) met the PFS endpoint as a first-line treatment of HER2+, locally advanced or metastatic gastroesophageal adenocarcinoma. (Ref 1) ❓ What are the current survival benchmarks for this indication? Special Designatio

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) +

December 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Johnson & Johnson Innovative Medicine 's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? Clinical Events 🔬 The Phase 3 STAR-221 trial o

December 1st Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Eli Lilly and Company 's pirtobrutinib (BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to Bristol Myers Squibb 's lisocab

November 4th Week, 2025 Regulatory Events 🎯 The EC granted approval to Bristol Myers Squibb 's lisocabtagene maraleucel (anti-CD19 CAR-T) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to AstraZeneca ’s neoadjuvant durvalumab (anti-PD-L1) + ch

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

November 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted full approval to Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. 's ziftomenib (menin inhibitor) for adult patients with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval expected to impact the Tx algorithm of AML? Clinical Events 🔬 In the Phase 3 PEAK trial, Cogent Biosciences ' bezuclastinib (KIT inhibitor) + sunitinib met the prim

November 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Johnson & Johnson 's Darzalex Faspro (daratumumab, an anti-CD38, and hyaluronidase) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of this indication? Clinical Events 🔬 In the registrational cohort of the Phase 2 IOV-LUN-202/NCT04614103 trial, Iovance Biotherapeutics, Inc. ’s lifileuc

10/11/2025 Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC ( Ref ) The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC. Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC Previously, zongertinib received accelerated approval by t

06/11/2025 Johnson & Johnson's Darzalex Faspro has been approved by the FDA for HR-SMM ( Ref ) The US FDA approved Johnson & Johnson's Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). The approval is based on results from the Ph3 AQUILA/NCT03301220 trial, which evaluated the efficacy and safety of Darzalex Faspro vs active monitoring (or “Watch and Wait”) in patients with

05/11/2025 Leukogene Therapeutics' LTI-214 received the FDA orphan drug designation for AML ( Ref ) The US FDA granted the orphan drug designation to Leukogene Therapeutics' LTI-214 (M2T-CD33; myeloid-targeted immunotherapy) for the treatment of Acute Myeloid Leukemia (AML). Sandeep Gupta, CEO, Leukogene: “ We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting Orphan Drug Designation. AML remains one of the most challenging hematologic canc