Belantamab mafodotin

After a yearslong struggle, Jazz Pharmaceuticals has called time on Zepzelca as a second-line treatment for small cell lung cancer. In alignment with the FDA, Jazz plans to ask the agency to remove the second-line SCLC indication from Zepzelca’s label, the company said Monday alongside its second-quarter earnings report. The decision comes after the confirmatory phase 3 Lagoon trial recently failed on its primary endpoint of overall survival. In the study, Zepzelca (lurbinectedin) monotherapy performed even worse than other chemotherapy regimens, while a combination of Zepzelca and irinotecan showed a numerical advantage that didn’t meet statistical significance. The withdrawal does not affect Zepzelca’s first-line maintenance approval as part of a combination with Roche’s Tecentriq for patients with extensive-stage SCLC. Zepzelca’s troubles quickly began to show after its initial FDA go-ahead in second-line SCLC. Just half a year after accelerated approval, the PharmaMar-partnered drug failed in the randomized phase 3 Atlantis trial, which evaluated the chemotherapy in tandem with doxorubicin versus the physician’s choice of chemo in second-line SCLC. Despite the flop, the FDA allowed Zepzelca to remain on the market and, in 2022, rejected a citizen petition calling for its withdrawal. At the time, the agency noted that the Atlantis study used a lower dose of Zepzelca than its approved version, and that an unmet medical need exists in second-line SCLC. Since then, the agency has approved Amgen’s T-cell engager Imdelltra in previously treated SCLC. The Lagoon trial used standard-dose Zepzelca for its single-agent regimen. Commercially, the first-line maintenance nod has given Zepzelca a boost. Sales of the drug in the second quarter increased 42% year over year to $106 million, as Jazz attributed the growth solely to its first-line use. Still, second-line uses make up the majority of Zepzelca’s uptake, with around 30% to 40% of the drug’s U.S. sales coming from the first-line setting, according to Jazz’s chief commercial officer, Sam Pearce, on an investor call Monday. Even before the withdrawal decision, Jazz had already seen a gradual decline in its second-line business due to competition. Now, “we may expect that to accelerate,” Pearce said. Cancer drugmakers have mostly been cooperative in withdrawing their drugs or indications after the FDA ramped up its post-accelerated approval scrutiny in recent years. In 2022, GSK quickly announced plans to remove its antibody-drug conjugate Blenrep merely days after a confirmatory trial flop in third-line multiple myeloma. The British pharma managed to reintroduce the drug as part of a combination last year after new phase 3 wins. Other oncology market withdrawals in recent years as a result of confirmatory trial setbacks include Takeda’s EGFR inhibitor Exkivity in lung cancer, Gilead’s ADC Trodelvy in bladder cancer and Ipsen’s EZH2 inhibitor Tazverik in blood cancer. The content above comes from the network. if any infringement, please contact us to modify.

GlaxoSmithKline (GSK) Pharmaceuticals has announced its financial results for the first quarter ended June 30, 2026. During the quarter, the company delivered strong growth across both its core and innovative portfolios. The performance reflects continued progress in the company's portfolio transformation strategy, supplemented by execution excellence, and a favorable base effect from the comparable period last year. Revenue for the quarter stood at INR 924 crore, up 15 percent Year-on-Year (YoY). Profit After Tax (PAT) increased by 24 percent to INR 253 crore, while EBITDA margins stood at 32 percent. The General Medicines portfolio grew strongly during the quarter, with the top 5 promoted brands outperforming the market (EI* >100; Source: IQVIA). Key promoted brands such as Augmentin, Ceftum and T-Bact reinforced their leadership positions in their respective categories, driven by a combination of deeper scientific and in-clinic engagement, omnichannel execution, and pricing measures. The Respiratory portfolio continued to further the management of chronic respiratory diseases with Nucala (mepolizumab) benefitting a large number of patients and Trelegy Ellipta gaining traction through new access pathways. The vaccines business grew through continued leadership in the self-pay private pediatric vaccines market, led by Infanrix Hexa and Fluarix Tetra. In the adult vaccination space, the company’s focus on elderly patient-cohorts with underlying Cardiovascular and Metabolic Diseases (CVMD) led to stronger endorsement from the healthcare professional community, translating to higher vaccinations with Shingrix (Recombinant Herpes Zoster Vaccine, Adjuvanted). The oncology business, led by specialised therapies Jemperli (dostarlimab) and Zejula (niraparib), has grown significantly since its launch in August last year. Jemperli is now the leading immunotherapy for first line primary advanced and recurrent endometrial cancer while Zejula is among the top PARP inhibitors in the maintenance treatment of recurrent ovarian cancer. Together, both therapies have touched the lives of a growing number of women suffering from gynecological malignancies, with GSK committed to expanding access and patient reach. Commenting on the results, Bhushan Akshikar, Managing Director (MD), GSK India, said, "GSK India's broad-based growth demonstrates the resilience of the core General Medicines and Vaccines portfolio and the growing contribution of the innovative business. This growth was enabled by a relentless focus on scientific excellence, sharper execution in the field and meaningful investments in technology and talent development. With a strong innovation pipeline and launch opportunities ahead, we are well-positioned to deliver sustainable growth and meaningful impact for millions of patients in India." The company has made progress in strengthening supply chain resilience through diversified sourcing, enhanced contingency planning and improved end-to-end visibility, substantially mitigating disruptions experienced in recent quarters. Looking ahead, GSK India is preparing for key pipeline launches. Blenrep (belantamab mafodotin), an anti-BCMA ADC therapy indicated for second-line treatment in relapsed or refractory multiple myeloma in adults, is set for launch. Arexvy, a vaccine to prevent Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults over 60 years of age and older adults (50 to 59 years) at high-risk, has received Marketing Authorisation (MA).