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FDA approves encorafenib combo for BRAF V600E+ metastatic CRC, ensartinib for ALK+ NSCLC, issues CRL to subcutaneous amivantamab BLA in EGFR+ NSCLC, seeks EU approval for ibrutinib plus R-CHOP in frontline MCL, and grants breakthrough therapy designation to sacituzumab govitecan for second-line ES-SCLC.

Gilead Sciences, Inc. (GILD) shares gained 15.4% in a year, outperforming the sector but lagging the S&P 500. New drug approvals, pipeline progress, and strong quarterly results boosted investor sentiment. GILD raised its annual guidance, driven by Veklury sales. Its HIV portfolio, led by Biktarvy, continues to grow, with lenacapavir showing 100% efficacy for HIV prevention. Seladelpar's approval for primary biliary cholangitis strengthens GILD's liver disease portfolio. Despite setbacks in oncology, Trodelvy received Breakthrough Therapy Designation for small cell lung cancer. GILD's strong fundamentals and dividend yield make it a good long-term investment.

Locally advanced/metastatic urothelial cancer (la/mUC) now has novel antibody drug conjugates (ADCs) like enfortumab vedotin (EV) and sacituzumab govitecan (SG) as treatment options. EV, with 40-52% response rates, gained FDA approval in 2023 for first-line use combined with pembrolizumab. SG, targeting TROP-2, is approved for late-line treatment with 27% ORR. Trastuzumab deruxtecan (T-DXd) offers another ADC option for HER2-positive solid tumors. Several new ADCs are under investigation in urothelial cancer clinical trials.

FDA granted Breakthrough Therapy Designation to Gilead's Trodelvy for ES-SCLC patients progressing after platinum-based chemotherapy, based on Phase II TROPiCS-03 study results. Trodelvy showed 41.9% ORR, 83.7% disease control rate, and median DOR of 4.7 months. ES-SCLC represents 70% of SCLC cases, with limited treatment options post-first-line therapy.

Gilead's Trodelvy granted second Breakthrough Therapy designation by FDA for extensive-stage small cell lung cancer, following promising phase II TROPiCS-03 study results.

FDA grants Gilead Sciences’ Trodelvy Breakthrough Therapy Designation for extensive-stage small cell lung cancer (ES-SCLC) post platinum-based chemotherapy. Based on Phase 2 TROPiCS-03 study results, Trodelvy showed promising antitumor activity and a consistent safety profile, prompting a planned Phase 3 trial.

Gilead Sciences announced FDA's Breakthrough Therapy Designation for Trodelvy for treating extensive-stage small cell lung cancer (ES-SCLC) post platinum-based chemotherapy. Based on Phase 2 TROPiCS-03 study results, Trodelvy showed promising antitumor activity and a consistent safety profile, prompting plans for a Phase 3 trial. Lung cancer, especially SCLC, has high mortality rates, and there's an urgent need for effective treatments.