7 FDA Lung Cancer Approvals in 24 Months Every Doctor Should Know

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This World Lung Cancer Day, I want to skip the ribbon-and-hashtag version of this conversation and go straight to what's changed in the last two years — because for oncologists, pulmonologists, and thoracic surgeons, the pace of approval has outrun the pace at which most of us can track cost and access alongside efficacy.
Here are seven approvals reshaping how lung cancer is treated, with the data — and the price tag — for each.
Relapsed small cell lung cancer finally has a new option. Amgen's tarlatamab-dlle (Imdelltra), a first-in-class DLL3-directed bispecific T-cell engager, received full FDA approval in November 2025 on the strength of the confirmatory Phase 3 DeLLphi-304 trial: a 40% reduction in risk of death, median OS of 13.6 months versus 8.3 on standard chemotherapy. It's biweekly IV, step-up dosed to manage cytokine release syndrome. In the US it runs roughly $30,000/month. It isn't yet commercially available in India — access runs through Named Patient Import, at a total course cost of approximately Rs. 1.0–1.3 crore.
Resistant ROS1 disease and CNS involvement now have a real answer. GSK's zidesamtinib (Jideytro) — approved this July following GSK's acquisition of Nuvalent — is a next-generation, highly brain-penetrant ROS1 inhibitor built to overcome resistance mutations including the solvent-front G2032R, with a 44% overall response rate in previously treated patients. US list pricing runs $216,000–$264,000/year. It is not yet commercially available in India; access is through Named Patient Import, and — as with most drugs approved this recently — facilitators haven't published a fixed landed cost yet. Expect a quote broadly in line with the US annual price once conversion, logistics, and facilitator fees are added; get an exact figure from your import facilitator before quoting a number to a patient.
First-line ALK-positive disease has a stronger intracranial option. Xcovery's ensartinib (Ensacove) now holds first-line approval based on the eXALT3 trial — median PFS of 25.8 months, with stronger intracranial control than earlier-generation ALK inhibitors. It's more accessible than the two above: approximately Rs. 45,000–60,000 per pack via import channels, against roughly $180,000/year in the US.
The EGFR/MET combination lost its biggest practical drawback. Lazertinib (Lazcluze) plus amivantamab, a bispecific EGFR/MET antibody, is FDA-approved first-line for EGFR exon 19del/L858R disease, extending median PFS to 23.7 months (MARIPOSA). The barrier to using this combination has always been infusion time — up to five hours for amivantamab alone. That's now solved: the subcutaneous formulation, Rybrevant Faspro, co-formulated with hyaluronidase, cuts administration to five to seven minutes with substantially fewer infusion reactions. If chair time or reaction rates were ever a reason to hesitate, that reason is largely gone. On access: this combination is not yet commercially launched in India. International reference pricing (Canada's per-cycle costing) puts it in the range of $12,000–15,000 per 28-day cycle before Indian import duties and facilitator fees — treat this as a ballpark for counseling purposes, not a quotable figure, and confirm the landed cost through a Named Patient Import facilitator.
Resectable disease now has two curative-intent regimens with strong Indian access. AstraZeneca's durvalumab (Imfinzi), used perioperatively for Stage II–III disease, delivered a 17.2% pathological complete response rate and a 32% reduction in recurrence risk in the AEGEAN trial. For resected, early-stage ALK-positive patients specifically, Roche's alectinib (Alecensa) is now approved as a fixed two-year adjuvant therapy, with the ALINA trial showing a substantial reduction in recurrence or death. Both are commercially available in India, with patient assistance programs and generic alternatives narrowing the cost gap — access here is meaningfully less of a barrier than for the therapies above.
Osimertinib's role has quietly expanded into unresectable Stage III. Paired with chemotherapy under FLAURA2, osimertinib (Tagrisso) now extends first-line median PFS to 25.5 months in advanced EGFR-positive disease. And in a setting many of us hadn't previously considered for maintenance therapy — unresectable Stage III EGFR-mutated NSCLC after chemoradiation — the LAURA trial showed an 84% reduction in risk of progression or death with maintenance osimertinib. On cost: brand osimertinib runs Rs. 1.5–2 lakh/month in India, but bio-equivalent generics are now available for Rs. 8,000–15,000/month — worth raising explicitly when adherence over months or years is the real question.
The pattern worth naming
Access in India now falls into three distinct tiers: commercially available with generic pressure bringing costs down (durvalumab, alectinib, osimertinib); available via import at moderate cost (ensartinib); and available only via Named Patient Import at significant cost (tarlatamab, zidesamtinib). Knowing which tier a therapy sits in — before raising it with a patient — changes how that conversation goes.
Biomarker testing remains the gating step behind almost everything above. A therapy this precise is only as useful as the testing pathway that identifies who qualifies for it.
I'll be tracking how these access tiers shift over the coming year as more of these therapies move toward commercial launch in India. If you're seeing this play out differently in your own practice, I'd like to hear it.
Dr. Chandra Sekhar is Founder & Editor-in-Chief, TheRightDoctors.
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SupportTags: Lung Cancer | Non-small Cell Lung Cancer | Nsclc | Small Cell Lung Cancer | Sclc | Fda Approvals | Targeted Therapy | Immunotherapy | Precision Oncology | Biomarker Testing | Egfr | Alk | Ros1 | Osimertinib | Amivantamab | Durvalumab | Tarlatamab | Oncology | Cancer Treatment | India Pharma |











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