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Eyes on Cell and Gene Therapy Approvals & Expansion
- Jana Chisholm
- Jul 19
- 3 min read
This week we had Eyes On the Datroway approval, and the associated removal of REMS requirements for CAR-T Therapeutics, along with a Biocon deal with Regeneron, and Bharat Biotech expansion plans for CGT manufacturing.
FDA Approves AstraZeneca and Diaichi’s Datroway for EGFR-Mutated Lung Cancer and removed REMS requirements for CAR-T cell therapies. The U.S. Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan-dlnk) for the treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received EGFR-directed therapy and platinum-based chemotherapy. This marks the first approval of a TROP2-directed antibody-drug conjugate for lung cancer in the U.S.
Clinical trials showed a 45% objective response rate, signalling a significant advance in precision oncology and providing new hope for patients with limited treatment options. The approval also triggered a $45 million milestone payment from AstraZeneca to Daiichi Sankyo, highlighting the financial and clinical impact of this development.
In a move expected to boost the adoption of CAR-T cell therapies, the FDA has removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for all currently approved BCMA- and CD19-directed CAR-T treatments. The agency also reduced certain post-infusion restrictions, making these advanced therapies more accessible to patients. This regulatory change is anticipated to accelerate the uptake of CAR-T therapies for cancer, which have shown significant promise in treating haematological malignancies.
The FDA's removal of REMS requirements for CAR-T therapies impacts several companies involved in their development and commercialization in haematology. Specifically, companies like Bristol Myers Squibb (BMS), Gilead Sciences, Johnson & Johnson, and Novartis are directly affected. Their CAR-T products, including Abecma, Breyanzi, Yescarta, Tecartus, Carvykti, and Kymriah, will now be available with streamlined monitoring requirements.
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Biocon Biologics Secures US Market Entry for Yesafili (Eylea Biosimilar). Biocon Biologics has reached a settlement and licensing agreement with Regeneron, clearing the way for the U.S. launch of Yesafili, its biosimilar to Eylea, by the second half of 2026 or earlier under certain conditions.
Yesafili, already approved by the USFDA, is intended for the treatment of various ophthalmology conditions. This agreement marks a significant milestone for Biocon Biologics as it expands its presence in the U.S. biosimilars market. In addition, Biocon has received approval from Health Canada for its Eylea biosimilar. The authorisation, granted via a Notice of Compliance (NOC) covers both vial and prefilled syringe formulations(2mg/0.05ml). Yesafili is set to launch in Canada in July 4th.
Biocon is the first company to launch a biosimilar to Eylea and Canada will be the first country where Biocon will launch Yesafili. Yesafili will be Biocon’s tenth biosimilar launch with a portfolio of biosimilars including insulin, trastuzimab and pegfilgrastim. Biocon’s trastuzimab and pegfilgrastim were the first biosimilars of the original molecules to be approved and launched in the US market. The company has a pipeline of 20 biosimilars products in development and will continue to be a leading provider of biosimilar drugs across the globe.
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Bharat Biotech has invested $75 million in its first cell and gene therapy facility in Telangana, India, with plans to launch new therapies by 2028. The company is focusing on oncology and rare diseases, aiming to develop cost-effective treatments for the Indian market and potential export.
The facility will address scientific challenges such as targeted gene expression, immune modulation, and long-term cell survival, targeting conditions like cancer and genetic diseases such as haemophilia. Bharat’s new facility will focus on advanced viral vector production, designed to produce high-titre viral vectors including adeno-associated viruses (AAVs), lentivirus, and adenovirus, essential for CGT production. The facility will have the capacity to manufacture multiple platform products for various disease indications. This facility will support a wide array of advanced therapies, including CD19 CAR T cell therapy for blood cancers and gene therapy.
Bharat Biotech aims to produce human-grade vectors for clinical trials, positioning India at the forefront of the global fight against rare and complex diseases. Krishna Ella was recently quoted, “Bharat aims to democratize gene therapies. Our established expertise in producing viral vectors is essential for cell and gene therapy applications – the crucial material for anti-cancer and genetic disorders and robust clinical development abilities for QC release.” This ambition is akin to what Kiran Mazumdar-Shaw, Biocon’s executive chairperson, achieved with its pioneering work to develop and manufacture biosimilar insulin.
Bharat Biotech has a significant partnership with GSK for developing and commercializing the Shigella vaccine candidate, altSonflex1-2-3. Bharat Biotech will lead the development, including clinical trials and manufacturing, while GSK will support with clinical trial design, funding, and commercialization strategy. This collaboration builds on a previous agreement where GSK transferred malaria vaccine production technology to Bharat Biotech.
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